Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of HIV-1 Chimp Adenovirus Vaccines Expressing Clade C gp140 & CH505TF gp120 Protein Boost in HIV-uninfected Adult.

Inclusion Criteria

General and Demographic Criteria

• Age of 18 through 50 years.
• Access to a participating HVTN 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 that in a previous trial with an adenovirus type 5 (Ad5) vector there was an association of increased HIV acquisition with receipt of that study product; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly.
• Willing to be contacted annually after completion of scheduled clinic visits for a total of 3 years following initial study injection.
• Agrees not to enroll in another study of an investigational research agent until the last scheduled 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 as "low risk" for HIV acquisition per low risk guidelines (see Appendix M), agrees to discuss HIV infection risks, agrees to risk reduction counseling, and agrees to avoid behavior associated with high risk of HIV exposure through the final study visit. Low risk may include persons stably taking PrEP as prescribed for 6 months or longer.

Laboratory Inclusion Values

Hemogram/Complete blood count (CBC)

• Hemoglobin
• 11.0 g/dL for volunteers who were assigned female sex at birth
• 13.0 g/dL for volunteers who were assigned male sex at birth and transgender male who have been on hormone therapy for more than 6 consecutive months
• 12.0 g/dL for transgender female who have been on hormone therapy for more than 6 consecutive months

For transgender participants who have been on hormone therapy for less than 6 consecutive months, determine hemoglobin eligibility based on the sex assigned at birth

• White blood cell count = 2, 500 to 12,000 cells/mm3 with normal differential, or differential approved by Investigator of Record (IoR) or designee as not clinically significant
• Total lymphocyte count ≥ 650 cells/mm3 with normal differential, or differential approved by Investigator of Record (IoR) or designee as not clinically significant
• Remaining differential either within institutional normal range or with site physician approval.
• Platelets = 125,000 to 550,000 cells/mm3.

Chemistry

• Alanine aminotransferase (ALT) 45, systolic blood pressure > 140 mm Hg, diastolic blood pressure > 90 mm Hg, current tobacco smoker, known hyperlipidemia.
• Intent to participate in another study of an investigational research agent or any other study that requires non-HVTN HIV antibody testing during the planned duration of the HVTN 139 study.
• Pregnant or breastfeeding.
• Active duty and reserve US military personnel.

Vaccines and other Injections

• HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 139 PSRT will determine eligibility on a case-by-case basis.
• Previous receipt of monoclonal antibodies (mAbs), whether licensed or investigational. Exceptions may be made by the HVTN 139 PSRT on a case-by-case basis.
• Non-HIV experimental vaccine(s) received within the last 1 year in a prior vaccine trial. Exceptions may be made by the HVTN 139 PSRT for vaccines that have subsequently undergone licensure by the FDA. For volunteers who have received control/placebo in an experimental vaccine trial, the HVTN 139 PSRT will determine eligibility on a case-by-case basis. For volunteers who have received an experimental vaccine(s) greater than 1 years ago, eligibility for enrollment will be determined by the HVTN 139 PSRT on a case-by-case basis.
• Live attenuated vaccines received within 30 days before first vaccination or scheduled