A Safety and Immune Response Study of 2 Experimental HIV Vaccines

NCT02404311 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: HVTN 100
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 5

Brief Summary

The HIV Vaccine Trials Network (HVTN) is doing a study to test a new HIV vaccine combination. HIV is the virus that causes AIDS. 252 people are taking part in this study at multiple sites. The US National Institutes of Health (NIH) is paying for the study. The investigators are doing this study to answer several questions.

• Are the study vaccines safe to give to people?
• Are people able to take the study vaccines without becoming too uncomfortable?
• How do people's immune systems respond to the study vaccines? (Your immune system protects you from disease.)

Conditions

HIV Infection

Keywords

HIV; AIDS; Vaccine

Outcome Measures

Primary Outcomes (27)

• Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen

  Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\] The maximum grade observed for each symptom over the time frame is presented.

  Measured through 3 days after participants' last vaccination at Month 0,1,3, and 6

• Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen

  Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\]

  Measured through 3 days after each vaccination at Month 0, 1, 3, and 6

• Part A: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity

  From the study termination form, early termination reasons associated with an AE or reactogenicity are tabulated by treatment arm

  Measured through Month 18

• Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity

  From the study product discontinuation form, study product administration reasons are tabulated by treatment arm

  Measured through the Month 12 vaccination

• Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher

  Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.

  Measured during screening for part A, and 2 weeks after each vaccination at Month 0, 1, 3, 6, and 12

• Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT

  For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.

  Time Frame: Measured during screening for part A, and 2 weeks after each vaccination at Month 0, 1, 3, 6, and 12

• Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine

  For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.

  Time Frame: Measured during screening for part A, and 2 weeks after each vaccination at Month 0, 1, 3, 6, and 12

• Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils

  For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.

  Measured during screening for part A, and 2 weeks after each vaccination at Month 0, 1, 3, 6, and 12

• Part A: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Primary Vaccine Regimen, Measured by HIV-1 Multiplex Antibody Assay

  Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.

  Measured at Month 6.5

• Part A: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Primary Vaccine Regimen, Measured by HIV-1 Multiplex Antibody Assay

  Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.

  Measured at Month 6.5

• Part A: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Primary Vaccine Regimen

  Measured by HIV-1 multiplex Ab assay: refer to earlier description for assay methods and analysis variable derivation. The number and percentage of participants with positive responses are summarized by antigen.

  Measured at Month 6.5

• Part A: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Primary Vaccine Regimen

  Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.

  Measured at Month 6.5

• Part A: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Primary Vaccine Regimen. Measured by Flow Cytometry.

  PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p\<=0.00001. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.

  Measured at Month 6.5

• Part A: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Primary Vaccine Regimen.

  Measured by flow cytometry ICS assay: refer to earlier description for assay methods and analysis variable derivation. Percentage of T-cells expressing cytokines are summarized for positive responders only.

  Measured at Month 6.5

• Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study

  Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\]. For each participant, the maximum grade observed for each symptom over the time frame is presented.

  Measured through 3 days after the Month 30 vaccination

• Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study

  Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\]. For each participant, the maximum grade observed for each symptom over the time frame is presented.

  Measured through 3 days after the Month 30 vaccination

• Part B: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity

  From the study termination form, early termination reasons associated with an AE are tabulated by treatment arm

  Measured through Month 36

• Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher

  Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.

  Time Frame: Measured during screening for part B, and 2 weeks after vaccination at Month 30

• Part B Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT

  For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.

  Measured during screening for part B, and 2 weeks after vaccination at Month 30

• Part B Chemistry Laboratory Measures: Hemoglobin, Creatinine

  For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.

  Measured during screening for part B, and 2 weeks after vaccination at Month 30

• Part B Chemistry Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils

  For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.

  Measured during screening for part B, and 2 weeks after vaccination at Month 30

• Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study

  Measured by HIV-1 multiplex Ab assay: refer to earlier description for assay methods and analysis variable derivation. The number and percentage of participants with positive responses are summarized by antigen.

  Measured at Month 30.5

• Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study

  Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.

  Measured at Month 30.5

• Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study

  Measured by HIV-1 multiplex Ab assay: refer to earlier description for assay methods and analysis variable derivation. The number and percentage of participants with positive responses are summarized by antigen.

  Measured at Month 30.5

• Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study

  Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.

  Measured at Month 30.5

• Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study

  Measured by flow cytometry ICS assay: refer to earlier description for assay methods and analysis variable derivation. The number and percentage of participants with positive responses are summarized by peptide pool.

  Measured at Month 30.5

• Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study

  Measured by flow cytometry ICS assay: refer to earlier description for assay methods and analysis variable derivation. Percentage of T-cells expressing cytokines are summarized for positive responders only.

  Measured at Month 30.5

Secondary Outcomes (14)

• Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination

  Measured through 3 days after each vaccination at Month 0, 1, 3, 6, and 12

• Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination

  Measured through 3 days after each vaccination at Month 0, 1, 3, 6, and 12

• Part A: Compare the Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Fourth Versus the Fifth Vaccination

  Measured at Month 6.5 and 12.5

• Part A: Compare the Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Fourth Versus the Fifth Vaccination

  Measured at Month 6.5 and 12.5

• Part A: Compare the Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Fourth Versus the Fifth Vaccination

  Measured at Month 6.5 and 12.5

Study Arms (5)

Part A, Group 1: Vaccine

ACTIVE COMPARATOR

ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12

Biological: ALVAC-HIV; Biological: Bivalent Subtype C gp120/MF59®

Part A, Group 2: Placebo

PLACEBO COMPARATOR

Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12

Biological: ALVAC-HIV (vCP2438) Placebo; Biological: Bivalent gp120/MF59® Placebo

Part B, Group 1a: Vaccine

ACTIVE COMPARATOR

Participants originally in Part A Group 1 (Vaccine) receive ALVAC-HIV + bivalent subtype C gp120/MF59 at month 30

Biological: ALVAC-HIV; Biological: Bivalent Subtype C gp120/MF59®

Part B, Group 1b: Vaccine + Placebo

ACTIVE COMPARATOR

Participants originally in Part A Group 1 (Vaccine) receive placebo for ALVAC-HIV + bivalent subtype C gp120/MF59 at month 30

Biological: Bivalent Subtype C gp120/MF59®; Biological: ALVAC-HIV (vCP2438) Placebo

Part B, Group 2: Placebo

PLACEBO COMPARATOR

Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30

Biological: ALVAC-HIV (vCP2438) Placebo; Biological: Bivalent gp120/MF59® Placebo

Interventions

ALVAC-HIV BIOLOGICAL

a lyophilized vaccine for injection at a viral titer ≥ 1 × 10E6 cell culture infectious dose (CCID)50 and \< 1 × 10E8 CCID50 (nominal dose of 10E7 CCID50) and is reconstituted with 1mL of sterile sodium chloride solution (NaCl 0.4%) for intramuscular (IM) injection as a single dose.

Part A, Group 1: Vaccine; Part B, Group 1a: Vaccine

Bivalent Subtype C gp120/MF59® BIOLOGICAL

2 recombinant monomeric proteins, each at a dose of 100 mcg, mixed with MF59® adjuvant (an oil-in-water emulsion) delivered as a 0.5 mL IM injection

Part A, Group 1: Vaccine; Part B, Group 1a: Vaccine; Part B, Group 1b: Vaccine + Placebo

ALVAC-HIV (vCP2438) Placebo BIOLOGICAL

a sterile, lyophilized product that consists of a mixture of virus stabilizer, and freeze drying medium and is reconstituted with 1mL of sterile sodium chloride solution (NaCl 0.4%) for injection as a single dose IM

Part A, Group 2: Placebo; Part B, Group 1b: Vaccine + Placebo; Part B, Group 2: Placebo

Bivalent gp120/MF59® Placebo BIOLOGICAL

Sodium chloride for injection, 0,9% delivered as a 0.5 mL IM injection

Part A, Group 2: Placebo; Part B, Group 2: Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age of 18 to 40 years
• Access to a participating HVTN CRS and willingness to be followed for the planned duration of the study
• Ability and willingness to provide informed consent
• Assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly
• Agrees not to enroll in another study of an investigational research agent
• Good general health as shown by medical history, physical exam, and screening laboratory tests
• Willingness to receive HIV test results
• Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling
• Assessed by the clinic staff as being at "low risk" for HIV infection (per Low Risk Guidelines for South African sites) and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit
• Hemoglobin ≥ 11.0 g/dL for volunteers who were born female, ≥ 13.0 g/dL for volunteers who were born male
• WBC = 3,300 to 12,000 cells/mm3
• Total lymphocyte count ≥ 800 cells/mm3
• Remaining differential either within institutional normal range or with site physician approval
• Platelets = 125,000 to 550,000/mm3
• Chemistry panel: ALT, AST, and ALP \< 1.25 times the institutional upper limit of normal; creatinine ≤ institutional upper limit of normal.

You may not qualify if:

• Blood products received within 120 days before first vaccination
• Investigational research agents received within 30 days before first vaccination
• Body mass index (BMI) ≥ 40; or BMI ≥ 35 with 2 or more of the following: systolic blood pressure \> 140 mm Hg, diastolic blood pressure \> 90 mm Hg, current smoker, known hyperlipidemia
• Intent to participate in another study of an investigational research agent or any study that includes HIV testing during the planned duration of the HVTN 100 study
• Pregnant, breastfeeding, or lactating
• HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 100 PSRT will determine eligibility on a case-by-case basis.
• Non-HIV experimental vaccine(s) received within the last 5 years in a prior vaccine trial. Exceptions may be made for vaccines that have subsequently undergone licensure by the South Africa Medicines Control Council (MCC). For volunteers who have received control/placebo in an experimental vaccine trial, the HVTN 100 PSRT will determine eligibility on a case-by-case basis. For volunteers who have received an experimental vaccine(s) greater than 5 years ago, eligibility for enrollment will be determined by the HVTN 100 PSRT on a case-by-case basis.
• Live attenuated vaccines other than influenza vaccine received within 30 days before first vaccination or scheduled within 14 days after injection (eg, measles, mumps, and rubella \[MMR\]; oral polio vaccine \[OPV\]; varicella; yellow fever)
• Influenza vaccine or any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (eg, tetanus, pneumococcal, Hepatitis A or B)
• Allergy treatment with antigen injections within 30 days before first vaccination or that are scheduled within 14 days after first vaccination
• Immunosuppressive medications received within 168 days before first vaccination. (Not excluded from participation: \[1\] corticosteroid nasal spray; \[2\] inhaled corticosteroids; \[3\] topical corticosteroids for mild, uncomplicated dermatitis; or \[4\] a single course of oral/parenteral corticosteroids at doses \< 2 mg/kg/day and length of therapy \< 11 days with completion at least 30 days prior to enrollment.)
• Serious adverse reactions to vaccines or to vaccine components such as eggs, egg products, or neomycin, including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded from participation: a volunteer who had a nonanaphylactic adverse reaction to pertussis vaccine as a child.)
• Immunoglobulin received within 60 days before first vaccination
• Autoimmune disease
• Immunodeficiency

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• HIV Vaccine Trials Network: collaborator
• Bill and Melinda Gates Foundation: collaborator
• Medical Research Council: collaborator
• Sanofi Pasteur, a Sanofi Company: collaborator
• GlaxoSmithKline: collaborator

Study Sites (5)

CAPRISA eThekwini CRS

Durban, KwaZulu-Natal, 4001, South Africa

Location

Isipingo CRS

Durban, KwaZulu-Natal, 4133, South Africa

Location

Emavundleni Desmond Tutu HIV Centre CRS

Cape Town, Western Cape, 7750, South Africa

Location

Aurum Institute for Health Research

Klerksdorp, 2570, South Africa

Location

Perinatal HIV Research Unit

Soweto, 2013, South Africa

Location

Related Publications (6)

• Moodie Z, Li SS, Giorgi EE, Williams LD, Dintwe O, Carpp LN, Chen S, Seaton KE, Sawant SS, Zhang L, Heptinstall J, Liu S, Grunenberg N, Tomaka F, Rerks-Ngarm S, Pitisuttithum P, Nitayaphan S, Ake JA, Vasan S, Pantaleo G, Frank I, Baden LR, Goepfert PA, Keefer M, Chirenje M, Hosseinipour MC, Mngadi K, Laher F, Garrett N, Bekker LG, De Rosa S, Andersen-Nissen E, Kublin JG, Lu S, Gilbert PB, Gray GE, Corey L, McElrath MJ, Tomaras GD. A polyvalent DNA prime with matched polyvalent protein/GLA-SE boost regimen elicited the most robust and broad IgG and IgG3 V1V2 binding antibody and CD4+ T cell responses among 13 HIV vaccine trials. Emerg Microbes Infect. 2025 Dec;14(1):2485317. doi: 10.1080/22221751.2025.2485317. Epub 2025 Apr 7.

  PMID: 40190112 DERIVED

• Naicker V, Laher F, Bekker LG, Seaton KE, Allen M, De Rosa S, Yates NL, Mkhize NN, Saunders K, Heptinstall J, Malahleha M, Mngadi K, Daniels B, Innes C, Yu C, Modise T, Bekker V, Grunenberg N, Furch B, Miner MD, Phogat S, Diazgranados CA, Gurunathan S, Koutsoukos M, Van Der Meeren O, Roxby AC, Ferrari G, Morris L, Montefiori D, McElrath MJ, Tomaras GD, Moodie Z. Safety and immunogenicity after a 30-month boost of a subtype C ALVAC-HIV (vCP2438) vaccine prime plus bivalent subtype C gp120/MF59 vaccine boost (HVTN 100): A phase 1-2 randomized double-blind placebo-controlled trial. PLOS Glob Public Health. 2024 Sep 20;4(9):e0003319. doi: 10.1371/journal.pgph.0003319. eCollection 2024.

  PMID: 39302924 DERIVED

• Hanass-Hancock J, Carpenter B, Reddy T, Nzuza A, Gaffoor Z, Goga A, Andrasik M. Participants' characteristics and motivations to screen for HIV vaccine and monoclonal antibody trials in KwaZulu-Natal, South Africa. Trials. 2021 Dec 11;22(1):897. doi: 10.1186/s13063-021-05792-7.

  PMID: 34895272 DERIVED

• Laher F, Moodie Z, Cohen KW, Grunenberg N, Bekker LG, Allen M, Frahm N, Yates NL, Morris L, Malahleha M, Mngadi K, Daniels B, Innes C, Saunders K, Grant S, Yu C, Gilbert PB, Phogat S, DiazGranados CA, Koutsoukos M, Van Der Meeren O, Bentley C, Mkhize NN, Pensiero MN, Mehra VL, Kublin JG, Corey L, Montefiori DC, Gray GE, McElrath MJ, Tomaras GD. Safety and immune responses after a 12-month booster in healthy HIV-uninfected adults in HVTN 100 in South Africa: A randomized double-blind placebo-controlled trial of ALVAC-HIV (vCP2438) and bivalent subtype C gp120/MF59 vaccines. PLoS Med. 2020 Feb 24;17(2):e1003038. doi: 10.1371/journal.pmed.1003038. eCollection 2020 Feb.

  PMID: 32092060 DERIVED

• Zhao LP, Fiore-Gartland A, Carpp LN, Cohen KW, Rouphael N, Fleurs L, Dintwe O, Zhao M, Moodie Z, Fong Y, Garrett N, Huang Y, Innes C, Janes HE, Lazarus E, Michael NL, Nitayaphan S, Pitisuttithum P, Rerks-Ngarm S, Robb ML, De Rosa SC, Corey L, Gray GE, Seaton KE, Yates NL, McElrath MJ, Frahm N, Tomaras GD, Gilbert PB. Landscapes of binding antibody and T-cell responses to pox-protein HIV vaccines in Thais and South Africans. PLoS One. 2020 Jan 30;15(1):e0226803. doi: 10.1371/journal.pone.0226803. eCollection 2020.

  PMID: 31999736 DERIVED

• Bekker LG, Moodie Z, Grunenberg N, Laher F, Tomaras GD, Cohen KW, Allen M, Malahleha M, Mngadi K, Daniels B, Innes C, Bentley C, Frahm N, Morris DE, Morris L, Mkhize NN, Montefiori DC, Sarzotti-Kelsoe M, Grant S, Yu C, Mehra VL, Pensiero MN, Phogat S, DiazGranados CA, Barnett SW, Kanesa-Thasan N, Koutsoukos M, Michael NL, Robb ML, Kublin JG, Gilbert PB, Corey L, Gray GE, McElrath MJ; HVTN 100 Protocol Team. Subtype C ALVAC-HIV and bivalent subtype C gp120/MF59 HIV-1 vaccine in low-risk, HIV-uninfected, South African adults: a phase 1/2 trial. Lancet HIV. 2018 Jul;5(7):e366-e378. doi: 10.1016/S2352-3018(18)30071-7. Epub 2018 Jun 18.

  PMID: 29898870 DERIVED

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

AIDSVAX

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Results Point of Contact

• Title: Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations
• Organization: Fred Hutchinson Cancer Research Center

jandries@fredhutch.org

206-667-5812

Study Officials

• Linda-Gail Bekker, MBChB, DTMH, DCH, FCP(SA), PhD

  HIV Vaccine Trials Network

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2015
• First Posted: March 31, 2015
• Study Start: February 2, 2015
• Primary Completion: August 7, 2018
• Study Completion: August 7, 2018
• Last Updated: November 5, 2021
• Results First Posted: October 19, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (5)