Status:
COMPLETED
A Phase I Study of Safety and Immunogenicity of the WRAIR HIV-1 Vaccine
Lead Sponsor:
U.S. Army Medical Research and Development Command
Collaborating Sponsors:
Walter Reed Army Institute of Research (WRAIR)
Conditions:
HIV Infections
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
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 in...
Detailed Description
The study seeks to enroll healthy, vaccine naïve volunteers, 18 through 45 years old. Recruitment consists of using flyers, newspaper advertising, radio, and direct mailing at local military installat...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 20 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00412477
Start Date
August 20 2004
End Date
November 1 2006
Last Update
October 10 2018
Active Locations (1)
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1
Vaccine Clinical Research Center
Rockville, Maryland, United States, 20850