Evaluating the Immunogenicity of the AIDSVAX B/E Vaccine and the MVA/HIV62B Vaccine in Healthy, HIV-1-Uninfected Adults Who Previously Received MVA/HIV62B in DNA/MVA or MVA/MVA Regimens in HVTN 205

Completed · Phase 1 · Has a placebo group

Conditions studied: HIV Infections

In brief

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the AIDSVAX B/E vaccine and the MVA/HIV62B vaccine in healthy, HIV-1-uninfected adults who previously received MVA/HIV62B in DNA/MVA or MVA/MVA vaccine regimens in the HVTN 205 study.

Key facts

Study ID: NCT02852005
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 27
Starts: 2017-01-01
Expected to finish: 2019-10-29
Last updated by the study team: 2022-08-08

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

General and Demographic Criteria:
Age of 18 to 55 years
Prior participation in HVTN 205 with assignment to treatment (not placebo) arm:
Assigned to HVTN 205 Group 1 or Group 3, and received all 4 scheduled vaccinations (2 injections of pGA2/JS7 DNA (months 0, 2) and 2 injections of MVA/HIV62 (months 4, 6); OR
Assigned to HVTN 205 Group 4, and received at least vaccinations 1, 2 and 4 (3 injections of MVA/HIV62 at months 0, 2 and 6).
Access to a participating 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; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly
Willing to be contacted 2 years following initial study injection.
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
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.
Laboratory Inclusion Values:
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
Remaining differential either within institutional normal range or with site physician approval
Platelets equal to 125,000 to 550,000/mm\^3
Chemistry
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 institutional upper limit of normal.
Cardiac Troponin T or I (cTnT or cTnI) does not exceed the institutional upper limit of normal

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
Volunteer has 2 or more of the following cardiac risk factors:
Participant report of history of elevated blood cholesterol defined as fasting LDL greater than 160 mg/dL;
First degree relative (eg, mother, father, brother, or sister) who had coronary artery disease before the age of 50 years;
Current smoker; or
BMI greater than or equal to 35
Pregnant or breastfeeding
Active duty and reserve U.S. military personnel
Vaccines and Other Injections
Any clinically significant AE related to vaccination in HVTN 205, for which revaccination would be a safety concern such as any grade 3 or 4 related AE
Smallpox vaccine received within the last 5 years
HIV vaccine(s) received in a prior HIV vaccine trial other than HVTN 205. For HVTN 205 participants who have subsequently received control/placebo in another HIV vaccine trial, the HVTN 114 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 FDA. For volunteers who have received control/placebo in an experimental vaccine trial, the HVTN 114 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 114 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
Immune System
Immunosuppressive medications received within 168 days before first vaccination. (Not exclusionary: [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 less than 2 mg/kg/day and length of therapy less than 11 days with completion at least 30 days prior to enrollment.)
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.)
Hypersensitivity to eggs or egg products
Immunoglobulin received within 60 days before first vaccination
Autoimmune disease (eg, myositis)

Where it is running

Alabama CRS — Birmingham, Alabama, United States
Bridge HIV CRS — San Francisco, California, United States
The Hope Clinic of the Emory Vaccine Center CRS — Decatur, Georgia, United States
Brigham and Women's Hospital Vaccine CRS (BWH VCRS) — Boston, Massachusetts, United States
Columbia P&S CRS — New York, New York, United States
University of Rochester Vaccines to Prevent HIV Infection CRS — Rochester, New York, United States
Seattle Vaccine and Prevention CRS — Seattle, Washington, United States
ACSA CRS — Iquitos, Maynas, Peru
Barranco CRS — Lima, Peru

Full record on ClinicalTrials.gov

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