Phase 2
N=334
Evaluating the Safety and Immunogenicity of HIV Clade C DNA Vaccine and MF59- or AS01B-Adjuvanted Clade C Env Protein Vaccines in Various Combinations in Healthy, HIV-Uninfected Adults
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT02915016 ↗Enrolled (actual)
334
Serious AEs
1.2%
Results posted
Sep 2020
Primary outcome: Primary: Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness — 5; 7; 6; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- DNA-HIV-PT123 vaccine (Biological); Bivalent Subtype C gp120/MF59 vaccine (Biological); Bivalent Subtype C gp120/AS01B vaccine (Biological); Placebo (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness |
5; 7; 6; 8; 10; 5 | — |
| PRIMARY Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration |
26; 35; 38; 23; 34; 36 | — |
| PRIMARY Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms |
14; 20; 18; 18; 16; 11 | — |
| PRIMARY Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product |
3; 2; 1; 5; 4; 4 | — |
| PRIMARY Number of Participants Reporting Adverse Events (AEs), by Severity Grade |
11; 13; 10; 6; 19; 8 | — |
| PRIMARY Number of Participants Reporting Serious Adverse Events (SAEs) |
0; 1; 0; 1; 1; 1 | — |
| PRIMARY Number of Participants Reporting Adverse Events of Special Interest (AESIs) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants Reporting New Chronic Conditions (Requiring Medical Intervention for ≥ 30 Days) |
0; 0; 0; 0; 0; 0 | — |
| 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 |
1; 0; 0; 0; 0; 0 | — |
| PRIMARY Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase. |
15; 14.5; 15; 13.5; 16.5; 16 | — |
| PRIMARY Chemistry and Hematology Laboratory Measures - Creatinine. |
0.795; 0.8; 0.8; 0.79; 0.77; 0.715 | — |
| PRIMARY Chemistry and Hematology Laboratory Measures - Hemoglobin. |
14.15; 14.3; 14.2; 14.2; 14.2; 14.5 | — |
| PRIMARY Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils. |
4060.5; 3540; 3108.5; 3919; 3616; 3505 | — |
| PRIMARY Chemistry and Hematology Laboratory Measures - Platelets, WBC. |
6.53; 6.45; 5.94; 6.665; 6.35; 5.94 | — |
| PRIMARY Numbers of Participants With Grade 1 or Higher Local Laboratory Results. |
0; 0; 0; 0; 0; 1 | — |
| PRIMARY Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates. |
19; 41; 42; 24; 39; 33 | — |
| PRIMARY Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes. |
22000; 22000; 22000; 22000; 22000; 22000 | — |
| PRIMARY Occurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Responses - Positive Response Rates. |
19; 42; 43; 24; 39; 36 | — |
| PRIMARY Occurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Response - Magnitudes. |
22000; 22000; 22000; 22000; 22000; 22000 | — |
| PRIMARY Occurrence and Level of Neutralizing Antibody Responses Against HIV-1 Isolates. |
— | — |
| PRIMARY Occurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates. |
20; 47; 43; 21; 42; 40 | — |
| PRIMARY Occurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes. |
0.237; 0.388; 0.492; 0.156; 0.364; 0.48 | — |
| PRIMARY Occurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates. |
2; 2; 11; 1; 4; 6 | — |
| PRIMARY Occurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes. |
0.007; 0.019; 0.026; 0.012; 0.019; 0.006 | — |
Summary
This study will evaluate the safety and immune response to the DNA-HIV-PT123 vaccine used in combination with one of two protein vaccines (Bivalent Subtype C gp120/MF59 or Bivalent Subtype C gp120/AS01B) in healthy, HIV-uninfected adults.
Eligibility Criteria
Inclusion Criteria
General and Demographic Criteria
- Age of 18 to 40 years
- 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
- Agrees not to enroll in another study of an investigational research agent before the last required protocol clinic visit
- Willing to be contacted by phone, text message, or e-mail 6 months after completion of the scheduled clinic visits
- 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: ALT, 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 FDA-approved enzyme immunoassay (EIA). Non-US sites may use locally available assays that have been approved by HVTN Laboratory Operations.
- 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:
United States
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 through the last required protocol clinic visit. Effective contraception for participants in the United States is defined as using any 1 or more of the following methods:
- Condoms (male or female) with or without a spermicide,
- Diaphragm or cervical cap with spermicide,
- Intrauterine device (IUD),
- Hormonal contraception, or
- 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
- Any other contraceptive method approved by the HVTN 108 protocol safety review team (PSRT)
- Or not be of reproductive potential, such as having reached menopause (no menses for 1 year) or havi
Data sourced from ClinicalTrials.gov (NCT02915016). 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.