Safety of and Immune Response to a Prime-Boost Vaccine Regimen in HIV-Uninfected Vaccine-Naive Adults
A Phase 2a Clinical Trial to Evaluate the Safety and Immunogenicity of a Prime-boost Vaccine Regimen of pGA2/JS7 DNA and MVA/HIV62, in Healthy, HIV Uninfected Vaccinia-naive Adult Participants
2 other identifiers
interventional
299
2 countries
12
Brief Summary
The purpose of this study is to evaluate the safety of and immune response to a two-vaccine regimen in healthy, HIV-uninfected adults who have never received an HIV preventive vaccine before.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hiv-infections
Started Jan 2009
Longer than P75 for phase_2 hiv-infections
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 8, 2009
CompletedFirst Posted
Study publicly available on registry
January 12, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedAugust 9, 2022
August 1, 2022
3.6 years
January 8, 2009
August 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Frequency of severe local and systemic reactogenicity signs and symptoms
Throughout study
Frequency of adverse events and assessed relationship to study products
Throughout study
Laboratory measures of safety, including boxplots of white blood cells (WBC), neutrophils, lymphocytes, hemoglobin, platelets, alanine aminotransferase (ALT), creatinine, and cardiac troponin results at baseline and following vaccination
At study entry and following vaccinations
Number of participants with early discontinuation of vaccinations, by treatment group and reason for discontinuation
Throughout study
Secondary Outcomes (6)
Responses to individual HIV potential T-cell epitope (PTE) peptide pools representing Env, Gag, and Pol
Throughout study
Percentage of responding CD4+ and CD8+ T cells producing interferon (IFN)-gamma, interleukin (IL)-2, tumor necrosis factor (TNF)-alpha, CD57, perforin, or granzyme B or demonstrating other functions
Measured at study completion
Frequency and titer of humoral responses detected by HIV binding antibody assays to p55 Gag and gp140 Env
Measured at study completion
Frequency of vaccine-induced positive results with end of study HIV serological testing by commercial assays
Measured at study completion
Frequency of CD4+ T-cell responses
Measured 2 weeks following last MVA vaccination
- +1 more secondary outcomes
Study Arms (5)
Part A, Group 1
EXPERIMENTALParticipants will receive two injections of the pGA2/JS7 DNA vaccine and then two injections of the MVA/HIV62 vaccine
Part A, Group 2
PLACEBO COMPARATORParticipants will receive four placebo injections
Part B, Group 3
EXPERIMENTALParticipants will receive two injections of the pGA2/JS7 DNA vaccine and then two injections of the MVA/HIV62 vaccine
Part B, Group 4
EXPERIMENTALParticipants will receive three injections of the MVA/HIV62 vaccine and one injection of the placebo
Part B, Group 5
PLACEBO COMPARATORParticipants will receive four placebo injections
Interventions
1 mL of recombinant modified vaccinia Ankara/HIV clade B gag-pol-env (MVA/HIV62)
Eligibility Criteria
You may qualify if:
- Access to a participating HIV Vaccine Trials Network (HVTN) clinical research center and willing to be followed for the planned duration of the study
- Ability and willingness to provide informed consent
- Assessment of understanding: completion of a questionnaire prior to first vaccination; demonstration of understanding for all questionnaire items answered incorrectly
- Willingness to receive HIV test results
- Good general health as shown by medical history, physical exam, and screening laboratory tests
- Certain specified laboratory values. More information on this criterion can be found in the study protocol.
- If pregnancy is possible, must agree to use contraception from at least 21 days prior to enrollment through the last protocol visit for sexual activity that could lead to pregnancy. More information on this criterion can be found in the study protocol.
- Willingness to discuss HIV infection risks, amenable to HIV risk reduction counseling, committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit, and willing to continue annual follow-up contact after the last required protocol clinic visit for a total of 5 years following enrollment
- Assessed by clinic staff as being at "low risk" of HIV infection on the basis of sexual behaviors within the 12 months prior to enrollment. More information on this criterion can be found in the study protocol.
You may not qualify if:
- HIV vaccine(s) or other experimental vaccines, received in a prior HIV vaccine trial. More information on this criterion can be found in the study protocol.
- Receipt of smallpox vaccination
- Excessive alcohol use, frequent binge drinking, chronic marijuana abuse, or use of any other illicit drugs, such as cocaine or methamphetamine, within the past 12 months
- History of newly acquired or newly diagnosed syphilis; history of newly acquired gonorrhea, nongonococcal urethritis, herpes simplex virus type 2 (HSV2), chlamydia, pelvic inflammatory disease (PID), trichomonas, mucopurulent cervicitis,epididymitis, proctitis, lymphogranuloma venereum, chancroid, or hepatitis B within the past 12 months
- Immunosuppressive medication received within 168 days before first vaccination. Certain medications are excluded from this criterion; more information can be found in the study protocol.
- Blood products received within 120 days before first vaccination
- Immunoglobulin received within 60 days before first vaccination
- Live attenuated vaccines other than influenza vaccine received within 30 days before first vaccination or scheduled within 14 days after injection
- Influenza vaccine or any vaccines that are not live attenuated and were received within 14 days prior to first vaccination or that are scheduled within 14 days after injection
- Allergy treatment with antigen injections within 30 days before first vaccination or scheduled within 14 days after injection
- Intent to participate in another study of an investigational research agent during the planned duration of this study
- Current anti-tuberculosis (TB) prophylaxis or therapy
- Clinically significant medical condition. More information on this criterion can be found in the study protocol.
- Any medical, psychiatric, or social condition or occupational or other responsibility that in the opinion of the investigator might interfere with the study protocol
- Serious adverse reactions to vaccines. More information on this criterion can be found in the study protocol.
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Alabama CRS
Birmingham, Alabama, 35294, United States
Bridge HIV CRS
San Francisco, California, 94143, United States
The Hope Clinic of the Emory Vaccine Center CRS
Decatur, Georgia, 30030, United States
Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
Boston, Massachusetts, 02115-6110, United States
Fenway Health (FH) CRS
Boston, Massachusetts, 02215-4302, United States
Columbia P&S CRS
New York, New York, 10032-3732, United States
New York Blood Center CRS
New York, New York, 10065, United States
University of Rochester Vaccines to Prevent HIV Infection CRS
Rochester, New York, 14642, United States
Vanderbilt Vaccine (VV) CRS
Nashville, Tennessee, 37232-2582, United States
Seattle Vaccine and Prevention CRS
Seattle, Washington, 98109-1024, United States
ACSA CRS
Iquitos, Maynas, 1, Peru
Barranco CRS
Lima, 04, Peru
Related Publications (4)
Miedema F. A brief history of HIV vaccine research: stepping back to the drawing board? AIDS. 2008 Sep 12;22(14):1699-703. doi: 10.1097/QAD.0b013e3283021a61.
PMID: 18753857BACKGROUNDRerks-Ngarm S, Brown AE, Khamboonruang C, Thongcharoen P, Kunasol P. HIV/AIDS preventive vaccine 'prime-boost' phase III trial: foundations and initial lessons learned from Thailand. AIDS. 2006 Jul 13;20(11):1471-9. doi: 10.1097/01.aids.0000237362.26370.f8. No abstract available.
PMID: 16847401BACKGROUNDGoepfert PA, Elizaga ML, Seaton K, Tomaras GD, Montefiori DC, Sato A, Hural J, DeRosa SC, Kalams SA, McElrath MJ, Keefer MC, Baden LR, Lama JR, Sanchez J, Mulligan MJ, Buchbinder SP, Hammer SM, Koblin BA, Pensiero M, Butler C, Moss B, Robinson HL; HVTN 205 Study Group; National Institutes of Allergy and Infectious Diseases HIV Vaccines Trials Network. Specificity and 6-month durability of immune responses induced by DNA and recombinant modified vaccinia Ankara vaccines expressing HIV-1 virus-like particles. J Infect Dis. 2014 Jul 1;210(1):99-110. doi: 10.1093/infdis/jiu003. Epub 2014 Jan 7.
PMID: 24403557BACKGROUNDHuang Y, Zhang L, Janes H, Frahm N, Isaacs A, Kim JH, Montefiori D, McElrath MJ, Tomaras GD, Gilbert PB. Predictors of durable immune responses six months after the last vaccination in preventive HIV vaccine trials. Vaccine. 2017 Feb 22;35(8):1184-1193. doi: 10.1016/j.vaccine.2016.09.053. Epub 2017 Jan 25.
PMID: 28131393DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Paul A Goepfert, MD
UAB, Div. of Infectious Diseases
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2009
First Posted
January 12, 2009
Study Start
January 1, 2009
Primary Completion
August 1, 2012
Study Completion
September 1, 2014
Last Updated
August 9, 2022
Record last verified: 2022-08