A Phase I Study of Safety and Immunogenicity of the WRAIR HIV-1 Vaccine

Completed · Phase 1

Conditions studied: HIV Infections

In brief

To evaluate the safety of LFn-p24 administered at three different doses with Alhydrogel given intramuscularly To evaluate immune responses to LFn-p24 with Alhydrogel at three different doses given intramuscularly

Key facts

Study ID

NCT00412477

Run by

U.S. Army Medical Research and Development Command

People needed

18

Starts

2004-08-20

Expected to finish

2006-11-01

Last updated by the study team

2018-10-10

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Citizens of the U.S.A. who are not at high-risk for HIV infection.
• Age: 18 through 45 years of age.
• For women, negative serum pregnancy test will be required within two days prior to any injection, as well as verbal assurance that adequate contraceptive measures are applied.
• Good health as determined by medical history, physical examination, and clinical judgment.
• Clinical laboratory values at screening within the following ranges:
• Hematocrit: Women: > 34%: Men >38% (Mild anemia in any potential trial volunteer who is otherwise healthy attributable by appropriate laboratory studies to thalassemia minor will not be cause for exclusion)
• White blood cell count: 3,000 to 12,000 cells/mm3
• Platelets: 125,000 to 550,000 per mm3
• Chemistry Panel: Expanded chemistry panel within institutional normal ranges or accompanied by site physician approval.
• Urine dipstick for protein and blood: negative or trace. If either is ≥ 1+, obtain complete urinalysis (UA). If microscopic UA confirms evidence of hematuria or proteinuria ≥ 1+, the volunteer is ineligible unless menstruating, then a repeat UA is required.
• Negative serology for HIV infection (ELISA test).
• Availability for at least 52 weeks
• Successful completion of the Test of Understanding, Commitment for Trial Participation and signature of the approved Trial Consent Form.

You may not qualify if…

• Acknowledge engaging in highest-risk behavior within 48 weeks of study entry: (i.e., active injecting drug use or having sexual intercourse with a known HIV-1 infected partner).
• Have active tuberculosis or other systemic infectious process by review of systems and physical examination.
• Have a history of immunodeficiency, chronic illness requiring continuous or frequent medical intervention, autoimmune disease, or use of immunosuppressive medications.
• Have evidence of psychiatric, medical and/or substance abuse problems during the past 48 weeks that the investigator believes would adversely affect the volunteer's ability to participate in the trial.
• Have occupational or other responsibilities that would prevent completion of participation in the study.
• Have received any live, attenuated vaccine within 60 days of study entry.
• NOTE: Medically indicated subunit or killed vaccines (e.g., Hepatitis A or Hepatitis B) are not exclusionary but should be given at least 2 weeks before or after HIV immunization to avoid potential confusion of adverse reactions.
• Acute or chronic Hepatitis caused by viral or other etiology.
• Have used experimental therapeutic agents within 30 days of study entry.
• Have received blood products or immunoglobulins in the past 12 weeks.
• Have a history of anaphylaxis or other serious adverse reactions to vaccines.
• Have previously received an HIV and/or anthrax vaccine.
• Currently enrolled in other vaccine trials.
• Are pregnant or lactating.
• NOTE: Women of child-bearing potential must be using effective contraception from the date of enrollment into the protocol.
• Have an immediate type hypersensitivity reaction to aminoglyocides, e.g., kanamycin (used to prepare the LFn-p24 vaccine).
• Are study site employees who are involved in the protocol and may have direct access to the immunogenicity results.
• Are receiving ongoing therapy with immunosuppressive therapy such as systemic corticosteroids or cancer chemotherapy.
• Are active duty military or reserves.

Where it is running

• Vaccine Clinical Research Center — Rockville, Maryland, United States

Full record on ClinicalTrials.gov

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