A Phase I Study of Prime-Boost HIV Vaccine Combinations

Not Applicable

• Conditions: HIV/AIDS

• Registration Number: PACTR201304000534302
• Lead Sponsor: Janssen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-24
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Other
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Able to read and willing to complete the informed consent process.
2. ¿ 18 to 50 years old at the time of study enrollment (enrollment is defined as the time of first vaccination, but a participant must be 18 at time of consent).
3. Healthy adults (determined by medical history, physical examination, and clinical
judgement).
4. Laboratory criteria within 56 days prior to enrollment:
o Hemoglobin: Women: ¿11 g/dL; ¿Men 12.5 g/dL
o White cell count: 2,500 to 11,000 cells/mm3
o Platelets: 125,000 to 450,000 per mm3
o Urinalysis: protein and blood <1+, glucose negative
o ALT/AST¿1.25x institutional upper limits of normal, and creatinine ¿1.25x
institutional upper limits of normal.
5. Negative for HIV infection (negative U.S. FDA-approved HIV diagnostic blood test).
6. All female subjects must:
o Have a negative pregnancy test at the screening visit;
o Have a negative pregnancy test immediately prior to each vaccine/placebo
vaccination;
o Provide verbal assurance that adequate birth control measures have been
followed for 56 days prior to the first vaccine/placebo vaccination and will
continue to be followed for at least 3 months 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, diaphragms;
¿ Intrauterine device (IUD) or
¿ Abstinence.
7. Available and willing to participate for the duration of the study visits and follow up.
8. Amenable to HIV risk reduction counseling and committed to maintaining behavior
consistent with low risk of HIV exposure through the last required protocol clinic visit.
9. Pass the Test of Understanding.
10. Must be willing to provide verifiable identification.
11. Must have a means to be contacted.
12. Assessed by the clinic staff as being at low risk for HIV infection.

Exclusion Criteria

1. Confirmed HIV-1/-2 infection.
2. Chronic active hepatitis B or active hepatitis C or active syphilis infection.
3. A woman who is breastfeeding.
4. Any clinically significant acute or chronic medical condition that in the opinion of the investigator would preclude participation.
5. Major surgery within the 4 weeks prior to study entry or planned major surgery through the course of the study.
6. History of myocarditis, pericarditis, cardiomyopathy, congestive heart failure with
permanent sequelae, clinically significant arrhythmia.
7. ECG with clinically significant findings, or features that would interfere with the assessment of myo/pericarditis.
8. History of diabetes mellitus type 1 or type 2, including cases controlled with diet alone. (Not excluded: history of isolated gestational diabetes.)
9. Thyroidectomy, or thyroid disease requiring medication during the last 12 months.
10. Hypertension.
11. Major psychiatric illness and/or substance abuse problems during the past 12 months that
in the opinion of the investigator would preclude participation.
12. Receipt of live attenuated vaccine within 30 days or plans to receive within 30 days postvaccination.
13. Use of experimental therapeutic agents within 30 days of study entry.
14. Current or planned participation in another clinical study during the study period.
15. Receipt of blood products or immunoglobulin in the past 3 months
16. History of anaphylaxis or other serious adverse reactions to vaccines or egg products or neomycin or streptomycin
17. History of chronic urticaria
18. Chronic or recurrent use of medications which modify host immune response, e.g. cancer chemotherapeutic agents, parenteral corticosteroids
19. Recipient of an HIV vaccine candidate at any time, receipt of a pox-virus vaccine in the last 10 years, and receipt of other experimental vaccine(s) within the last 5 years.
20. Subjects who cannot communicate reliably with the investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess safety and tolerability of each prime-boost regimen and Compare epitope mapping of homologous prime-boost regimens with MVA-vectors and either mosaic versus natural sequence inserts.