Phase 1
Completed N=27
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
Source: ClinicalTrials.gov NCT02852005 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcomePrimary: Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) — 0; 0; 0; 0 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) |
0; 0; 0; 0; 2; 1 | — |
| PRIMARY Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) |
3; 0; 4; 2; 1; 0 | — |
| PRIMARY Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen |
1; 0; 2; 2; 6; 1 | — |
| PRIMARY Number of Participants With Early Study Termination Associated With an AE or Reactogenicity |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L |
54.5; 63.5; 91; 78.5; 55; 59 | — |
| PRIMARY Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL |
14; 13.6; 13; 14.5; 14; 15 | — |
| PRIMARY Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils |
5.8; 6.27; 6.875; 6.4; 5.8; 6.3 | — |
| PRIMARY Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost |
1; 3; 2; 4; 7; 3 | — |
| PRIMARY Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost |
220.875; 8614; 196; 28087; 23785.75; 196 | — |
| PRIMARY Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost |
0; 0; 0; 2; 2; 0 | — |
| PRIMARY Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost |
1; 5.875; 1; 8; 6; 1 | — |
| PRIMARY Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost |
0; 3; 0; 4; 6; 0 | — |
| PRIMARY Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost |
1; 3035.25; 1; 4259.75; 808.25; 1 | — |
| PRIMARY Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost |
5; 5; 5; 5; 5; 5 | — |
| SECONDARY Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost |
0; 2; 2; 5; 4; 2 | — |
| SECONDARY Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost |
0.032; 0.074; 0.048; 0.142; 0.083; 0.04 | — |
| SECONDARY Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost |
0.008; 0.006; 0.004; 0.015; 0.002; 0.005 | — |
| SECONDARY Occurrence of Env-specific IgG Responses for gp120, gp140, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost |
0; 1; 0; 3; 6; 0 | — |
| SECONDARY Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost |
19; 443.5; 26.25; 2206.25; 758.25; 26.25 | — |
Eligibility Criteria
Inclusion Criteria
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
Virology
- Negative HIV-1 and -2 blood test: Participants must have a negative test result for HIV infection following the HVTN Lab Program's in-study HIV testing algorithm, prior to initial enrollment.
- Negative hepatitis B surface antigen (HBsAg)
- Negative anti-hepatitis C virus Ab (anti-HCV), or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive
Urine
- 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 with red blood cells levels within institutional normal range).
Reproductive Status
- Volunteers who were born female: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed prior to vaccination on the day of initial vaccination. Persons who are NOT of reproductive potential due to having undergone total hysterectomy or bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing.
- Reproductive status: A volunteer who was born female must:
- Agree to consistently use effective contraception (more information is available in the protocol) for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment through the last required protocol clinic visit. Effective contraception is defined as using the following methods:
- Condoms (male or female) with or without a spermicide,
- Diaphragm or cervical cap with spermicide,
- Intrauterine device (IUD),
- Hormonal contraception, or
- Any other contraceptive method approved by the HVTN 114 Protocol Safety Review Team (PSRT)
- Successful v
Data sourced from ClinicalTrials.gov (NCT02852005). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.