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Evaluating the Safety and Immune Response to an HIV Vaccine Boost Following the Administration of Two HIV Vaccines, in HIV-Uninfected, Healthy Adults (Study Extension to HVTN 073/SAAVI 102)

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Sub C gp140 Vaccine

MF59C.1 Adjuvant

Sodium chloride

About this trial

This is an interventional prevention trial for HIV Infections

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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:
1. Negative urine glucose, and
2. Negative or trace urine protein, and
3. 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

Exclusion Criteria:

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)

Sites / Locations

Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
Fenway Health (FH) CRS
Soweto HVTN CRS
Emavundleni CRS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sub C gp140/MF59C.1 Vaccine

Sodium chloride for injection

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Neutralizing antibody breadth against heterologous primary isolates

Full Information

NCT ID

NCT01423825

First Posted

August 24, 2011

Last Updated

October 13, 2021

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

1. Study Identification

Unique Protocol Identification Number

NCT01423825

Brief Title

Evaluating the Safety and Immune Response to an HIV Vaccine Boost Following the Administration of Two HIV Vaccines, in HIV-Uninfected, Healthy Adults (Study Extension to HVTN 073/SAAVI 102)

Official Title

A Phase 1 Placebo-Controlled Study Extension to HVTN 073 / SAAVI 102, to Evaluate the Safety and Immunogenicity of Novartis Sub C gp140 Vaccine With MF59 Adjuvant, as a Boost Following SAAVI DNA-C2 Vaccine and SAAVI MVA-C Vaccine, in HIV Uninfected Healthy Adult Participants in South Africa and the United States

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

August 2011 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

The HVTN 073/SAAVI 102 study is evaluating the safety of two experimental HIV vaccines-SAAVI DNA-C2 and SAAVI MVA-C-given sequentially as a prime-boost regimen in healthy, HIV-uninfected adults. This is an extension of that study and will enroll people who participated in the HVTN 073/SAAVI 102 study. Previous studies have shown that a protein vaccine boost to an HIV vaccine may improve antibody responses. This study will evaluate the safety and immune response to an HIV envelope protein vaccine-the Sub C gp140 vaccine with MF59 adjuvant-in healthy, HIV-uninfected adults who have previously participated in the HVTN 073/SAAVI 102 study. Study researchers will explore whether the addition of a protein boost vaccine to the SAAVI DNA-C2 and SAAVI MVA-C vaccine regimen improves antibody response. This study will enroll people who participated in the HVTN 073/SAAVI 102 study,regardless of whether they received vaccine or placebo. Participants will be randomly assigned to receive either the Sub C gp140 vaccine with MF59 adjuvant or a placebo injection during study visits at baseline and Month 3. At the baseline and Month 3 visits, participants will undergo a physical examination, HIV testing and counseling, pregnancy testing for female participants, interviews and questionnaires, risk reduction counseling, and blood collection (at the baseline visit only). They will then receive their assigned vaccine or placebo as one injection in their upper arm. Participants will remain in the clinic for 30 minutes after receiving the vaccination for observation and monitoring. For 3 days after the vaccination, participants will record any side effects in a symptom log and make contact daily with the study site staff. Additional study visits will occur at Weeks 1 and 2, 1 and 2 weeks after the Month 3 visit, and Months 6 and 9. At these visits, select baseline study procedures will occur. At Month 15, study staff will contact participants for follow-up health monitoring. Participants will then complete any annual health contacts for the original HVTN 073/SAAVI 102 study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sub C gp140/MF59C.1 Vaccine

Arm Type

Experimental

Arm Description

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.

Arm Title

Sodium chloride for injection

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Sub C gp140 Vaccine

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

MF59C.1 Adjuvant

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Sodium chloride

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

Measured through Month 15

Secondary Outcome Measure Information:

Title

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

Time Frame

Measured at Months 0.5, 3.5 and 9

Title

Neutralizing antibody breadth against heterologous primary isolates

Time Frame

Measured at Months 0.5, 3.5 and 9

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Glenda Gray

Organizational Affiliation

University of the Witswatersrand

Official's Role

Study Chair

Facility Information:

Facility Name

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

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115-6110

Country

United States

Facility Name

Fenway Health (FH) CRS

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215-4302

Country

United States

Facility Name

Soweto HVTN CRS

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

1864

Country

South Africa

Facility Name

Emavundleni CRS

City

Cape Town

State/Province

Western Cape Province

ZIP/Postal Code

7750

Country

South Africa

12. IPD Sharing Statement

Citations:

PubMed Identifier

19843557

Citation

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.

Results Reference

background

PubMed Identifier

10395842

Citation

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.

Results Reference

background

PubMed Identifier

18061231

Citation

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. Erratum In: Virology. 2008 Nov 25;381(2):287. Diaz-Avalos, Ruben [added].

Results Reference

background

PubMed Identifier

27098021

Citation

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.

Results Reference

derived

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Evaluating the Safety and Immune Response to an HIV Vaccine Boost Following the Administration of Two HIV Vaccines, in HIV-Uninfected, Healthy Adults (Study Extension to HVTN 073/SAAVI 102)

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