Phase 1
N=60
Evaluating the Safety and Immunogenicity of Env (A,B,C,A/E)/Gag (C) DNA and gp120 (A,B,C,A/E) Protein/GLA-SE HIV Vaccines, Given Individually or Co-administered, in Healthy, HIV-1-Uninfected Adults
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT03409276 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: Number of Participants Reporting Local Reactogenicity Signs and Symptoms — 2; 5; 5; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- env (A,B,C,A/E)/gag (C) DNA Vaccine (Biological); gp120 (A,B,C,A/E) Protein Vaccine (Biological); Placebo (Biological); GLA-SE adjuvant (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting Local Reactogenicity Signs and Symptoms |
2; 5; 5; 3; 1; 0 | — |
| PRIMARY Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms |
1; 5; 2; 4; 6; 1 | — |
| PRIMARY Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product |
0; 0; 0; 5; 2; 2 | — |
| PRIMARY Number of Participants Reporting Adverse Events (AEs), by Severity Grade |
0; 2; 1; 0; 2; 2 | — |
| PRIMARY Number of Participants Reporting Serious Adverse Events (SAEs) |
0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants Reporting Adverse Events of Special Interest (AESIs) |
0; 0; 0; 0; 0 | — |
| PRIMARY Numbers of Participants With Grade 1 or Higher Local Laboratory Results |
0; 1; 0; 0; 0; 1 | — |
| PRIMARY Alk Phos, AST, ALT in UL |
61; 59.5; 54.5; 61; 59; 57.5 | — |
| PRIMARY Hemoglobin, Creatinine in g/dL |
14.7; 13.75; 13.85; 14.7; 14.8; 14.65 | — |
| PRIMARY WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm |
5.1; 6.305; 5.9; 5.7; 6.4; 4.35 | — |
| PRIMARY Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation |
0; 0; 0; 0; 1; 0 | — |
| SECONDARY Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination |
0; 8; 0; 18; 13; 0 | — |
| SECONDARY Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination |
22000; 22000; 22000; 13847.8; 22000; 12427.5 | — |
| SECONDARY Breadth of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination |
2; 4; 2; 4.2; 4; 2 | — |
| SECONDARY Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination |
0; 16; 15; 0; 0; 0 | — |
| SECONDARY Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination |
10; 681.2; 583.5; 5; 5; 5 | — |
| SECONDARY Breadth of gp70-V1V2 IgG and gp120 IgA, Assessed by Binding Antibody Multiplex Assay, and ADCC Activities Against HIV-1 Subtypes A, B, C and A/E Two Weeks After the Last Vaccination in Part B |
0.2; 19; 11.4; 2.2; 31.8; 17.8 | — |
| SECONDARY Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. |
0; 19; 7; 0; 1; 0 | — |
| SECONDARY Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. |
-0.011; 0.313; 0.102; -0.001; 0.017; 0.001 | — |
| SECONDARY Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. |
-0.003; 0.007; -0.007; 0.002; -0.006; -0.004 | — |
Summary
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of env (A,B,C,A/E)/gag (C) DNA and gp120 (A,B,C,A/E) protein/GLA-SE HIV-1 vaccines (PDPHV-201401) as a prime-boost regimen or co-administered in repeated doses, in healthy, HIV-1-uninfected adults.
Eligibility Criteria
Inclusion Criteria
General and Demographic Criteria
- Age of 18 to 50 years
- Access to a participating HIV Vaccine Trials Network (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 12 months after the last vaccination
- 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/mm^3 to 450,000/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.
Virology
- Negative HIV-1 and -2 blood test: US volunteers must have a negative US Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA).
- Negative Hepatitis B surface antigen (HBsAg)
- Negative anti-Hepatitis C virus antibodies (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 (see the protocol for more information) for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment until after 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 124 Protocol Safety Review Team (PSRT)
- Successful vasectomy in the male partner (considered successful if a volunteer reports that a male partner has [1] documentation of azoospermia by microscopy, or [2] a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity postvasectomy);
- Or not be of reproductive potential, such as having reached menopause (no menses for 1 year) or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation;
- Or be sexually abstinent.
- Volunteers who were born female must also agree n
Data sourced from ClinicalTrials.gov (NCT03409276). 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.