Evaluating the Safety and Immunogenicity of an HIV Vaccine (gp145 C.6980) in Healthy, HIV-Uninfected Adults in the United States

NCT03382418 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: HVTN 12212030
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of an HIV vaccine (gp145 C.6980) with aluminum hydroxide adjuvant in healthy, HIV-1-uninfected adults in the United States.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (10)

• Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness

  Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Corrected Version 2.1, dated July 2017. The maximum grade observed for each symptom over the time frame is presented.

  Measured through 7 days after first vaccination at Month 0

• Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration

  Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Corrected Version 2.1, dated July 2017. The maximum grade observed for each symptom over the time frame is presented.

  Measured through 7 days after first vaccination at Month 0

• Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms

  Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Corrected Version 2.1, dated July 2017. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Reaction is the maximum of the individual systemic variables for a participant. It does not include temperature.

  Measured through 7 days after first vaccination at Month 0

• Number of Participants Reporting Adverse Events (AEs), by Severity Grade

  Severity definitions are found in The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017); For participants reporting multiple AEs over the time frame, the maximum severity grade is counted.

  Measured through 30 days after first vaccination at Month 0

• Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product

  Severity definitions are found in The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017); For participants reporting multiple AEs over the time frame, the maximum severity grade is counted.

  Measured through 30 days after first vaccination at Month 0

• Number of Participants Reporting Serious Adverse Events (SAEs)

  Measured as outlined in Version 2.0 (January 2010) of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual)

  Measured through 30 days after first vaccination at Month 0

• Chemistry and Hematology Laboratory Measures With Grade 1 or Higher, Through First Vaccination

  Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with grade 1 or higher results are shown.

  Measured at 2 weeks after first vaccination

• Hematology Laboratory Measures: WBC, Neutrophils , Lymphocytes and Platelets

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

  Measured at 2 weeks after first vaccination

• Chemistry Laboratory Measures: Hemoglobin, Creatinine

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

  Measured at 2 weeks after first vaccination

• Chemistry Laboratory Measures: ALT

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

  Measured at 2 weeks after first vaccination

Secondary Outcomes (18)

• Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness

  Measured through Month 6.5

• Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration

  Measured through Month 6.5

• Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms

  Measured through Month 6.5

• Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product

  Measured through Month 7

• Number of Participants Reporting Adverse Events (AEs), by Severity Grade

  Measured through Month 7

Study Arms (3)

Group 1: gp145 C.6980 (high dose)

EXPERIMENTAL

Participants will receive 300 mcg of the gp145 C.6980 vaccine admixed with aluminum hydroxide adjuvant at Day 0 and Months 2 and 6.

Biological: gp145 C.6980 Vaccine; Biological: Aluminum Hydroxide Adjuvant

Group 2: gp145 C.6980 (low dose)

EXPERIMENTAL

Participants will receive 100 mcg of the gp145 C.6980 vaccine admixed with aluminum hydroxide adjuvant at Day 0 and Months 2 and 6.

Biological: gp145 C.6980 Vaccine; Biological: Aluminum Hydroxide Adjuvant

Group 3: Placebo

PLACEBO COMPARATOR

Participants will receive placebo at Day 0 and Months 2 and 6.

Biological: Placebo

Interventions

gp145 C.6980 Vaccine BIOLOGICAL

Administered by intramuscular injection in the deltoid.

Also known as: HIV Env gp145 C.6980, recombinant oligomeric gp145 clade C Env protein

Group 1: gp145 C.6980 (high dose); Group 2: gp145 C.6980 (low dose)

Placebo BIOLOGICAL

Sodium Chloride for Injection, 0.9%; Administered by intramuscular injection in the deltoid.

Group 3: Placebo

Aluminum Hydroxide Adjuvant BIOLOGICAL

Administered by intramuscular injection in the deltoid.

Also known as: Aluminum Hydroxide Suspension

Group 1: gp145 C.6980 (high dose); Group 2: gp145 C.6980 (low dose)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• General and Demographic Criteria
• Age of 18 to 50 years
• Access to a participating HIV Vaccine Trials Network (HVTN) clinical research site (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 and completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items initially answered incorrectly
• Agrees not to enroll in another study of an investigational research agent before the last scheduled protocol clinic visit
• Good general health as shown by medical history, physical exam, and screening laboratory tests
• HIV-Related Criteria:
• 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 and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit. Low risk guidelines are found on the protocol web page under Study Materials on the HVTN Members' site (https://members.hvtn.org/protocols/hvtn122).
• Hemogram/Complete Blood Count (CBC)
• Hemoglobin greater than or equal to 11.0 g/dL for volunteers who were born female, greater than or equal to 13.0 g/dL for volunteers who were born male
• White blood cell count equal to 3,300 to 12,000 cells/mm\^3
• Total lymphocyte count greater than or equal to 800 cells/mm\^3

You may not qualify if:

• General
• Blood products received within 120 days before first vaccination
• Investigational research agents received within 30 days before first vaccination
• Body mass index (BMI) greater than or equal to 40; or BMI greater than or equal to 35 with 2 or more of the following: age greater than 45, systolic blood pressure greater than 140 mm Hg, diastolic blood pressure greater than 90 mm Hg, current smoker, known hyperlipidemia
• Intent to participate in another study of an investigational research agent or any other study that requires non-HVTN HIV antibody testing during the planned duration of the HVTN 122 study
• Pregnant or breastfeeding
• Active duty and reserve US military personnel
• Vaccines and other Injections
• HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 122 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 by the HVTN 122 PSRT for vaccines that have subsequently undergone licensure by the FDA. For volunteers who have received control/placebo in an experimental vaccine trial, the HVTN 122 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 122 PSRT on a case-by-case basis.
• Live attenuated vaccines other than influenza vaccine received within 30 days before or scheduled and intended to be received within 14 days after the first vaccination (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 and intended to be received within 14 days after first vaccination
• Immune System
• Serious adverse reactions to vaccines or to vaccine components, 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.)

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (3)

Columbia P&S CRS

New York, New York, 10032-3732, United States

Location

New York Blood Center CRS

New York, New York, 10065, United States

Location

Penn Prevention CRS

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Tieu HV, Karuna S, Huang Y, Sobieszczyk ME, Zheng H, Tomaras GD, Montefiori DC, Shen M, DeRosa S, Cohen K, Isaacs MB, Regenold S, Heptinstall J, Seaton KE, Sawant S, Furch B, Pensiero M, Corey L, Bar KJ; HVTN 122 Study Team. Safety and immunogenicity of a recombinant oligomeric gp145 subtype C Env protein (gp145 C.6980) HIV vaccine candidate in healthy, HIV-1-uninfected adult participants in the US. Vaccine. 2023 Oct 6;41(42):6309-6317. doi: 10.1016/j.vaccine.2023.07.046. Epub 2023 Sep 9.

  PMID: 37679276 DERIVED

MeSH Terms

Conditions

HIV Infections

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

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

• Katharine Bar

  University of Pennsylvania

  STUDY CHAIR

• Hong Van Tieu

  New York Blood Center

  STUDY CHAIR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: December 22, 2017
• Study Start: December 27, 2017
• Primary Completion: September 25, 2019
• Study Completion: September 25, 2019
• Last Updated: October 8, 2021
• Results First Posted: July 27, 2021

Record last verified: 2021-10

Locations

US (3)