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To Investigate Safety, Reactogenicity and Immunogenicity of VIR-1388 Compared With Placebo in Participants Without HIV

CompletedPhase 1

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Conditions: HIV I Infection

Interventions: VIR-1388, Placebo

Countries: United States, South Africa

The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity of VIR 1388 in adults in good health without HIV.

Eligibility overview

Sex: ALL

Age: 18 Years to 55 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* In overall good health as determined by medical history, physical exam, and laboratory values
* HIV uninfected
* CMV seropositive
* Willing to use condoms during intercourse for the duration of the study
* Assessed by clinic staff as being low risk for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last protocol visit
* Childbearing status

  * Part A: Only participants of non-childbearing potential
  * Part B: Participants of childbearing potential must be on 2 forms of contraception and not planning on becoming pregnant for the duration of the study

Exclusion Criteria:

* Participant is immunocompromised
* Participant has an autoimmune disorder
* Participants having intimate contact with immunocompromised individuals
* Participants having intimate contact with a pregnant partner or partner planning to become pregnant
* Participants who are breastfeeding

Locations (10)

Birmingham, Alabama, United States
Decatur, Georgia, United States
Boston, Massachusetts, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Seattle, Washington, United States
Soshanguve, Gauteng, South Africa
Soweto, Gauteng, South Africa
Isipingo, KwaZulu-Natal, South Africa
Overport, KwaZulu-Natal, South Africa