Comparative Adjuvant Study for Env-C DNA and Protein Vaccines in Kenya

Phase 1

• Conditions: HIV/AIDS

• Registration Number: PACTR202009737295685
• Lead Sponsor: IAID

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-30
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 126

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

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):
<1.0 x 103 cells/µL
13. Participant has received any of the following substances:
• Chronic use of therapies that may modify immune response, such as intravenous
(IV) immune globulin and systemic corticosteroids (in doses of >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

Study & Design

• Study Type: Interventional
• Study Design: Not specified