HIV/AIDS
Conditions
Interventions
Env C Plasmid DNA
HIV Env gp145 C.6980
Sponsors
NIAID
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: INCLUSION CRITERIA 1. Healthy, male and female participant aged 18 to 40 years and available for 26 months 2. Must be at low risk for HIV infection per investigator assessment and using the study risk assessment tool. 3. Must be able to understand and complete the informed consent process. 4. Must be capable of reading English or Kiswahili. 5. Must agree to a home visit. 6. Must complete a Test of Understanding (TOU) before enrollment. Must answer 9 out of 10 questions correctly, with a maximum of three attempts. 7. Must be in good general health without a clinically significant medical history. 8. HIV-uninfected per diagnostic algorithm within 45 days of enrollment. 9. Laboratory values: • Hemoglobin: 12.5-18.1 g/dL men 11.0-16.1 g/dL women • White Cell Count: 2.7-7.7 x 103 cells/µL men 3.0-9.1 x 103 cells/µL women • Platelets: 125-370 103 cells/µL men 125-444 103 cells/µL women • ALT and AST: =1.25 institutional upper limit of the reference range Creatinine: =1.25 institutional upper limit of the reference range • Urinalysis: (dipstick) for blood and protein less than 1+ and negative glucose Female-Specific Criteria: 10. Negative urine pregnancy test for women at screening, the day of each vaccination, and before any invasive procedure. 11. Already using and commits to continued use of an adequate birth control method for 45 days before to the first vaccine/placebo vaccination and for at least 90 days after the final vaccine/placebo vaccination. Adequate birth control is defined as follows: Contraceptive medications delivered orally, intramuscularly, vaginally, or implanted, underneath the skin, surgical methods (hysterectomy or bilateral tubal ligation), condoms with spermicide, diaphragms, intrauterine device (IUD
Exclusion criteria
Exclusion criteria: 1. Three or more sexual partners in the previous 24 weeks 2. Commercial sex work 3. Non-adherence to condom use in the absence of a long-term monogamous relationship 4. Intravenous drug use in the previous year. 5. A sexually transmitted infection in the previous 24 weeks 6. Asplenia: any condition resulting in the absence of a functional spleen 7. Bleeding disorder diagnosed by a medical doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) 8. Breastfeeding or pregnant (positive pregnancy test) women or planning to become pregnant during the window between study enrollment and three months after the last vaccination visit. 9. Any past, ongoing, or in remission history of treated or untreated autoimmune disease. 10. Has known active Hepatitis B virus infection (or positive HBsAg). 11. History of anaphylaxis or other serious adverse reaction to vaccines or allergies or reactions likely to be exacerbated by any component of the vaccine and placebo, including antibiotics or excipients 12. Absolute Neutrophil Count (ANC): 20 mg/day prednisone equivalent for periods exceeding 10 days) • The following exceptions are permitted and will not exclude study participation: o use of corticosteroid nasal spray for rhinitis, o topical corticosteroids for an acute uncomplicated dermatitis; or o A short course (10 days or less, or a single injection) of corticosteroid for a non-chronic condition (based on investigator clinical judgment) at least 2 weeks before enrollme
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reactogenicities systemic and local | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity | — |
Countries
Kenya
Contacts
Public ContactRael Bor
Study Coordinator
Outcome results
None listed