Phase 1
Completed N=45
Evaluating the Safety and Immunogenicity of an HIV Vaccine (gp145 C.6980) in Healthy, HIV-Uninfected Adults in the United States
Source: ClinicalTrials.gov NCT03382418 ↗Enrolled (actual)
45
Serious AEs
2.2%
Results posted
Jul 2021
Primary outcomePrimary: Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness — 9; 4; 4; 14 Participants
Summary
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of an HIV vaccine (gp145 C.6980) with aluminum hydroxide adjuvant in healthy, HIV-1-uninfected adults in the United States.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness |
6; 4; 4; 14; 10; 1 | — |
| PRIMARY Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration |
20; 14; 4; 3; 0; 1 | — |
| PRIMARY Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms |
14; 5; 4; 9; 8; 0 | — |
| PRIMARY Number of Participants Reporting Adverse Events (AEs), by Severity Grade |
5; 4; 0; 8; 3; 4 | — |
| PRIMARY Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product |
1; 0; 0; 14; 8; 4 | — |
| PRIMARY Number of Participants Reporting Serious Adverse Events (SAEs) |
0; 0; 0; 9; 3; 0 | — |
| PRIMARY Chemistry and Hematology Laboratory Measures With Grade 1 or Higher, Through First Vaccination |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Hematology Laboratory Measures: WBC, Neutrophils , Lymphocytes and Platelets |
6.10; 5.95; 6.80; 3.802; 3.523; 4.114 | — |
| PRIMARY Chemistry Laboratory Measures: Hemoglobin, Creatinine |
13.50; 12.75; 12.90; 0.00086; 0.00087; 0.00076 | — |
| PRIMARY Chemistry Laboratory Measures: ALT |
14; 15; 14 | — |
| SECONDARY Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness |
6; 4; 4; 14; 10; 1 | — |
| SECONDARY Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration |
20; 14; 4; 3; 0; 1 | — |
| SECONDARY Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms |
14; 5; 4; 9; 8; 0 | — |
| SECONDARY Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product |
1; 0; 0; 14; 8; 4 | — |
| SECONDARY Number of Participants Reporting Adverse Events (AEs), by Severity Grade |
5; 4; 0; 8; 3; 4 | — |
| SECONDARY Frequency of Serious Adverse Events (SAEs) |
1; 0; 0; 14; 8; 4 | — |
| SECONDARY Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations |
6.20; 6.45; 6.38; 6.10; 5.95; 6.80 | — |
| SECONDARY Chemistry Laboratory Measures: Hemoglobin, Creatinine, Through All Vaccinations |
14.20; 13.60; 14.20; 13.50; 12.75; 12.90 | — |
| SECONDARY Chemistry Laboratory Measures: ALT, Through All Vaccinations |
13; 14; 15; 14; 15; 14 | — |
| SECONDARY Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) |
17; 11; 0; 0; 0; 0 | — |
| SECONDARY Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) |
12189.8; 7134.2; 1.0; 20.2; 20.1; 2.4 | — |
| SECONDARY Occurrence of HIV-specific CD4+ and CD8+ T-cell Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. |
7; 5; 0; 5; 3; 0 | — |
| SECONDARY Levels of CD4+ and CD8+ T Cells Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. |
.109; .117; .008; .035; .038; -.002 | — |
| SECONDARY Occurrence of Neutralizing Antibody Responses Against HIV-1 Isolates |
0; 0; 0; 18; 8; 0 | — |
| SECONDARY Level of Neutralizing Antibody Responses Against HIV-1 Isolates |
5; 5; 5; 91; 30; 10 | — |
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 and completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items initially answered incorrectly
- Agrees not to enroll in another study of an investigational research agent before the last scheduled protocol clinic visit
- 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. Low risk guidelines are found on the protocol web page under Study Materials on the HVTN Members' site (https://members.hvtn.org/protocols/hvtn122).
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.
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 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 122 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
Data sourced from ClinicalTrials.gov (NCT03382418). 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.