A Phase 3, Randomized, Controlled, Open Label Study to Evaluate the Immunogenicity, Safety, and Tolerability of MF59-Adjuvanted Versus Non-Adjuvanted Vaccines Against Novel H1N1 Virus in Patients With Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- H1N1 Influenza Virus
- Sponsor
- Chiltern Pesquisa Clinica Ltda
- Enrollment
- 154
- Locations
- 2
- Primary Endpoint
- Geometric Mean HI Titer by Visit
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
This is a phase III, randomized, controlled, open label study with two vaccine regimens. The study will assess the relative safety and immunogenicity of vaccine regimens comparing adjuvanted versus non-adjuvanted formulations of A(H1N1) inactivated influenza virus vaccine in subjects with Human Immunodeficiency Virus Type 1 (HIV-1) Infection and to compare safety and immunogenicity data with a contemporaneously enrolled control group of age-comparable, healthy subjects.
Because certain individuals may be hypo-responsive to influenza vaccination, additional studies with high-risk groups are warranted in order to determine the optimal vaccine formulation and dosing schedule for prevention of novel H1N1 virus infection.
Investigators
Eligibility Criteria
Inclusion Criteria
- •For HIV-1 Infected Subjects:
- •Adults between 18-60 years old (inclusive)
- •Any sex or ethnicity
- •Confirmed Diagnosis of HIV-1 infection
- •CD4+ cells count \>200 per mm3 within 3 months prior to inclusion in the study
- •HIV-1 viral load below 200 copies/mL within 90 days prior to inclusion in the study
- •Childbearing potential women must be willing to use an acceptable contraceptive method. Acceptable contraceptive methods are defined as one or more of the following:
- •Hormone contraceptive (such as oral, injectable, transdermal patch, subcutaneous implant, cervical ring)
- •Barrier (condom with spermicide or diaphragm with spermicide) at each intercourse and during the whole intercourse
- •Intra-uterine device (IUD)
Exclusion Criteria
- •For HIV-1-Infected Subjects:
- •HIV-1 viral load above 500 copies/mL within 6 months prior to inclusion in the study
- •Previous laboratory confirmed diagnosis of an infection by the novel H1N1 virus
- •Receipt of another vaccine against the novel H1N1 virus within 3 months prior to inclusion in the study
- •Any recent vaccine given within the last 21 days (inclusive)
- •History of allergic reaction to an influenza vaccine in the past, or a current or previous occurrence of allergy to egg or egg protein, kanamycin, and neomycin sulfate
- •Acute febrile disease (vaccination may be delayed up to 3 days after the resolution of the symptoms)
- •History of cancer, except for skin cancer, including Kaposi's Sarcoma, basal cell carcinoma, and non-invasive malignancy related to HPV
- •History of cognitive disorders
- •History of progressive or severe neurological disorders, including Guillain-Barré Syndrome
Outcomes
Primary Outcomes
Geometric Mean HI Titer by Visit
Time Frame: 13 months after vaccination (Day 1, Day 22, Day 43, Day 133, Day 223 and Day 403)
Geometric mean hemagglutination inhibition (HI) titer = GMT
Percentage of Subjects Who Reached Seroprotection by Visit
Time Frame: 13 Months after vaccination (Day 22, Day 43, Day 133, Day 223 and Day 403)
The primary objective of this study is to determine the optimal influenza vaccination strategy in patients with HIV infection. The percentage of subjects that reached seroprotection in comparison to the pre-vaccination result are presented by visit. Seroprotection was defined as HI titer ≥40.
Difference in the Seroconversion Rates or Significant Increase by Visit (Vaccine With Adjuvant - Vaccine Without Adjuvant)
Time Frame: 13 Months after vaccination (Day 22, Day 43, Day 133, Day 223 and Day 403)
The primary objective of this study was to help determine the ideal strategy of vaccination against pandemic H1N1 influenza in subjects with invasive solid tumors/hematologic neoplasms. Comparisons were made by vaccine group using differences in the percentage of subjects with seroconversion/significant increase and were presented with 95% confidence intervals.
Secondary Outcomes
- Geometric Mean Ratio by Visit(13 months after vaccination (Day 22/Day1, Day 43/Day 1, Day 43/Day 22, Day 133/Day 43, Day 223/Day 43 and Day 403/Day 223))
- Ratio of Immunogenicity Data by Visit (Vaccine with Adjuvant:Vaccine Without Adjuvant)(13 months after vaccination (Day 1, Day 22, Day 22/Day1, Day 43, Day 43/Day 1, Day 43/Day 22, Day 133, Day 133/Day 43, Day 223, Day 223/Day 43 and Day 403, Day 403/Day 223))
- Percentage of Subjects Who Seroconverted or Had a Significant Increase in GMT by Visit(13 Months after vaccination (Day 22, Day 43, Day 133, Day 223 and Day 403))
- Difference in Seroprotection Rates by Visit (Vaccine with Adjuvant - Vaccine without Adjuvant)(13 months after vaccination (Day 22, Day 43, Day 133, Day 223, Day 403))