HIV Vaccine in HIV-uninfected Adults

Korábbi kezelés

• Volunteer has received any of the following substances:
  • Chronic use of therapies that may modify immune response, such as IV immune globulin and systemic corticosteroids (in doses of > 20 mg/day prednisone equivalent for periods exceeding 10 days) Note: The following exceptions are permitted and will not exclude study participation: use of corticosteroid nasal spray for rhinitis, topical corticosteroids for an acute uncomplicated dermatitis; or a short course (duration of 10 days or less, or a single injection) of corticosteroid for a non-chronic condition (based on investigator clinical judgment) at least 14 days prior to enrollment in this study
  • Blood products within 120 days prior to HIV screening
  • Immunoglobulins within 30 days prior to HIV screening
  • Any licensed vaccine within 14 days prior to study vaccine administration in the present study
  • Receipt of any investigational HIV vaccine other than RV306 products
  • Investigational research agents or vaccine within 30 days prior to enrollment in the present study
  • Receipt of a Coronavirus disease 2019 (COVID-19) vaccine that has been given Emergency Use Authorization (or those that become licensed) by the Thai FDA within 14 days prior to study vaccine administration in the present study Note: Volunteers receiving a COVID-19 vaccine that requires 2 doses will not be enrolled until 14 days after the second dose has been administered
  • Anti-tuberculosis prophylaxis or therapy during the past 90 days prior to enrollment
• Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder; disorder requiring lithium; or within 5 years prior to enrollment, a history of suicide ideation or attempt

Más betegség

• Asplenia: any condition resulting in the absence of a functional spleen
• History of allergic reaction, anaphylaxis, or other serious adverse reaction to vaccines or components of the vaccines
• Active sexually transmitted infection confirmed by clinical exam and diagnostic test
• Any medical, psychiatric, social condition, occupational reason, or other responsibility that, in the judgment of the investigator, is a contradiction to protocol compliance or impairs a volunteer's ability to give informed consent

Laborértékek

• Bleeding disorder diagnosed by a medical doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions)

Egyéb

• Study site employees who are involved in the protocol and/or may have direct access to study related area
  • Determination of a participants eligibility will be completed at screening. Final evaluation of eligibility will be based on the medical judgment of the principal investigator or designee based on his/her medical and research experience.

• Healthy, HIV-uninfected male and female participants
• Prior RV306 recipients who were randomized to receive active vaccine with late boosting at month 12, 15, or 18 and who completed all vaccinations
• Have a Thai identity card
• Must be at low risk for HIV infection per investigator assessment
• Must be able to understand and complete the informed consent process
• Must be capable of reading Thai
• Must successfully complete a Test of Understanding prior to enrollment
• Must be in good general health without clinically significant medical history
• HIV-uninfected per diagnostic algorithm within 45 days of enrollment
• Laboratory screening analysis:
  • Hemoglobin: Women ≥11.0 g/dL, Men ≥11.5 g/dL
  • White cell count: 4,000 to 11,000 cells/mm3
  • Platelets: 150,000 to 450,000/mm3
  • ALT and AST ≤1.25 institutional upper limit of reference range
  • Creatinine: ≤1.25 institutional upper limit of reference range
  • Urinalysis blood and protein no greater than 1+ and negative glucose
• Female-Specific Criteria:
  • Not currently pregnant or breastfeeding and not planning to become pregnant during the first 3 months after study vaccine/placebo injections
  • Negative pregnancy test for women at screening, prior to vaccination (same day), and prior to any of the invasive procedures
  • Be using an adequate birth control method for 45 days prior to receipt of vaccine/placebo and for at least 3 months after receipt of the vaccine/placebo. 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, diaphragms, intrauterine device, or abstinence
• Male-Specific Criteria:
  • Be using an adequate birth control method for at least 3 months after receipt of the vaccine/placebo. For non-vasectomized male participants with female partners of child-bearing potential this includes the use of condoms or abstinence and/or their partner's use of contraceptive medications delivered orally, intramuscularly, vaginally, or implanted, underneath the skin, surgical methods (hysterectomy or bilateral tubal ligation), diaphragms, or intrauterine device.