High Dose Influenza in Immunosuppressed Subjects
|ClinicalTrials.gov Identifier: NCT00766285|
Recruitment Status : Withdrawn
First Posted : October 3, 2008
Last Update Posted : August 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Biological: Trivalent inactivated influenza vaccine Biological: Trivalent Baculovirus-expressed Influenza HA vaccine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Safety and Immunogenicity of High Dose Baculovirus-Expressed Recombinant Trivalent HA Influenza Vaccine in Adult Recipients of Allogeneic Hematopoietic Stem Cell Transplantation: Phase II Double-Blind Trial|
|Primary Completion Date :||September 2010|
|Study Completion Date :||September 2010|
Active Comparator: TIV
50 subjects to receive 45 mcg of TIV administered on Day 0 and Day 28.
Biological: Trivalent inactivated influenza vaccine
Standard trivalent influenza vaccine consisting of 15 mcg per antigen (45 mcg total) by intramuscular deltoid injection.
50 subjects to receive 405 mcg of rHAO administered on Day 0 and Day 28.
Biological: Trivalent Baculovirus-expressed Influenza HA vaccine
Influenza virus hemagglutinin proteins expressed in insect (SF+) cells under serum free conditions by recombinant baculovirus.
- Frequency of four-fold or greater serum hemagglutination inhibition (HAI) and/or neutralization antibody rises in the 2 groups to the 3 hemagglutinin (HA) types (H1, H3, and B) contained within the vaccine. [ Time Frame: At Days 28 and 56 after the first vaccine dose. ]
- The frequencies and severity of solicited local and systemic adverse events in each vaccine dosage group. [ Time Frame: Day 0 through Day 7 following all vaccinations. ]
- The geometric mean titer (GMT) of serum HAI and serum neutralizing antibody against the influenza A/H3N2, H1N1, and B virus. [ Time Frame: 1 month after each vaccination. ]
- The proportion of subjects in each vaccine dose group that achieves a HAI titer of at least 1:32. [ Time Frame: 28 days after the first and second dose of vaccine. ]
- Adverse events (AE) or serious adverse events (SAE) information (solicited in-clinic and via memory aids and periodic targeted physical assessment). [ Time Frame: Duration of study. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00766285
|United States, Texas|
|The University of Texas - MD Anderson Cancer Center - Infectious Diseases|
|Houston, Texas, United States, 77030-4000|