NCT01423825

Brief Summary

This is an extension of the HVTN 073/SAAVI 102 study. This study will evaluate the safety and immune response to an HIV envelope protein vaccine boost in people who have previously received the SAAVI DNA-C2 and SAAVI MVA-C vaccines or placebo in the HVTN 073/SAAVI 102 study.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1 hiv-infections

Timeline
Completed

Started Aug 2011

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

October 14, 2021

Status Verified

October 1, 2021

Enrollment Period

1.9 years

First QC Date

August 24, 2011

Last Update Submit

October 13, 2021

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

  • Safety data, including signs and symptoms of local and systemic reactogenicity, laboratory measures of safety, adverse events (AEs), and AEs requiring expedited adverse event (EAE) reporting to DAIDS

    Measured through Month 15

Secondary Outcomes (2)

  • HIV-1-specific neutralizing and binding antibody assays at 2 weeks following vaccination with Novartis Sub C gp140 with MF59

    Measured at Months 0.5, 3.5 and 9

  • Neutralizing antibody breadth against heterologous primary isolates

    Measured at Months 0.5, 3.5 and 9

Study Arms (2)

Sub C gp140/MF59C.1 Vaccine

EXPERIMENTAL

Participants will receive Sub C gp140 vaccine (100 mcg) admixed with MF59C.1 adjuvant administered as one 0.5 mL injection intramuscularly (IM) in either deltoid at baseline and Month 3.

Biological: Sub C gp140 VaccineBiological: MF59C.1 Adjuvant

Sodium chloride for injection

PLACEBO COMPARATOR

Participants will receive placebo injection administered as 0.5 mL IM in either deltoid at baseline and Month 3.

Other: Sodium chloride

Interventions

Sub C gp140 VaccineBIOLOGICAL

100 mcg of Sub C gp140 vaccine admixed with MF59C.1 adjuvant administered as one 0.5 mL injection intramuscularly (IM) in either deltoid

Sub C gp140/MF59C.1 Vaccine
MF59C.1 AdjuvantBIOLOGICAL

MF59C.1 adjuvant admixed with 100 mcg of Sub C gp140 vaccine administered as one 0.5 mL injection intramuscularly (IM) in either deltoid. MF59C.1 adjuvant contains no biologicals.

Sub C gp140/MF59C.1 Vaccine
Sodium chlorideOTHER

Sodium chloride as 0.5 mL IM injection in either deltoid to act as placebo

Sodium chloride for injection

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Hemoglobin greater than or equal to 11.0 g/dL
  • White blood cell (WBC) count greater than 2,500 cells/mm\^3
  • Platelets greater than or equal to 125,000/mm\^3
  • Chemistry panel: alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase less than 1.25 times the institutional upper limit of normal; creatinine less than or equal to the institutional upper limit of normal
  • Normal urine:
  • Negative urine glucose, and
  • Negative or trace urine protein, and
  • Negative or trace urine hemoglobin (if trace hemoglobin is present on dipstick, a microscopic urinalysis within institutional normal range)
  • Able and willing to provide informed consent
  • Negative HIV-1 and -2 blood test: Participants must have a negative HIV test result as specified by the HVTN Laboratory Program's in-study HIV diagnostic algorithm
  • Participants who were born female: negative serum or urine beta human chorionic gonadotropin (beta-HCG) pregnancy test performed on the day of initial study extension vaccination prior to vaccination
  • Reproductive status: A participant who was born female must agree to consistently use effective contraception from at least 21 days prior to enrollment through 90 days after the participant's final vaccination, for sexual activity that could lead to pregnancy. More information on this criterion can be found in the protocol.
  • Participants who were born female must also agree not to seek pregnancy through alternative methods such as artificial insemination or in vitro fertilization until after the last scheduled protocol visit
  • Receipt of scheduled injection at visit 11 in the HVTN 073/SAAVI 102 study

You may not qualify if:

  • Participant meets criteria for delay or discontinuation of vaccination or termination from the study. More information on this criterion can be found in the protocol.
  • Participant has an unresolved AE that is possibly, probably, or definitely related to the study product
  • Any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a participant's ability to give informed consent (e.g., a skin condition overlying a potential injection site, which could interfere with reactogenicity assessment)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Brigham and Women's Hospital Vaccine CRS (BWH VCRS)

Boston, Massachusetts, 02115-6110, United States

Location

Fenway Health (FH) CRS

Boston, Massachusetts, 02215-4302, United States

Location

Soweto HVTN CRS

Johannesburg, Gauteng, 1864, South Africa

Location

Emavundleni CRS

Cape Town, Western Cape, 7750, South Africa

Location

Related Publications (4)

  • Rerks-Ngarm S, Pitisuttithum P, Nitayaphan S, Kaewkungwal J, Chiu J, Paris R, Premsri N, Namwat C, de Souza M, Adams E, Benenson M, Gurunathan S, Tartaglia J, McNeil JG, Francis DP, Stablein D, Birx DL, Chunsuttiwat S, Khamboonruang C, Thongcharoen P, Robb ML, Michael NL, Kunasol P, Kim JH; MOPH-TAVEG Investigators. Vaccination with ALVAC and AIDSVAX to prevent HIV-1 infection in Thailand. N Engl J Med. 2009 Dec 3;361(23):2209-20. doi: 10.1056/NEJMoa0908492. Epub 2009 Oct 20.

    PMID: 19843557BACKGROUND

  • Evans TG, Keefer MC, Weinhold KJ, Wolff M, Montefiori D, Gorse GJ, Graham BS, McElrath MJ, Clements-Mann ML, Mulligan MJ, Fast P, Walker MC, Excler JL, Duliege AM, Tartaglia J. A canarypox vaccine expressing multiple human immunodeficiency virus type 1 genes given alone or with rgp120 elicits broad and durable CD8+ cytotoxic T lymphocyte responses in seronegative volunteers. J Infect Dis. 1999 Aug;180(2):290-8. doi: 10.1086/314895.

    PMID: 10395842BACKGROUND

  • Srivastava IK, Kan E, Sun Y, Sharma VA, Cisto J, Burke B, Lian Y, Hilt S, Biron Z, Hartog K, Stamatatos L, Diaz-Avalos R, Cheng RH, Ulmer JB, Barnett SW. Comparative evaluation of trimeric envelope glycoproteins derived from subtype C and B HIV-1 R5 isolates. Virology. 2008 Mar 15;372(2):273-90. doi: 10.1016/j.virol.2007.10.022. Epub 2007 Dec 3.

    PMID: 18061231BACKGROUND

  • Gray GE, Mayer KH, Elizaga ML, Bekker LG, Allen M, Morris L, Montefiori D, De Rosa SC, Sato A, Gu N, Tomaras GD, Tucker T, Barnett SW, Mkhize NN, Shen X, Downing K, Williamson C, Pensiero M, Corey L, Williamson AL. Subtype C gp140 Vaccine Boosts Immune Responses Primed by the South African AIDS Vaccine Initiative DNA-C2 and MVA-C HIV Vaccines after More than a 2-Year Gap. Clin Vaccine Immunol. 2016 Jun 6;23(6):496-506. doi: 10.1128/CVI.00717-15. Print 2016 Jun.

    PMID: 27098021DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Glenda Gray

    University of the Witswatersrand

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

August 24, 2011

First Posted

August 26, 2011

Study Start

August 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

October 14, 2021

Record last verified: 2021-10

Locations

US(2)ZA(2)