Primary Outcome Measures:
- The frequency of four-fold or greater serum HAI and/or neutralization antibody rises in the two groups to the three HA types (H1, H3, and B) contained within the vaccine at Days 28 and 56 after the first vaccine dose. [ Time Frame: Blood for antibody tests will be drawn at Day 0, 28 and 56. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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. ] [ Designated as safety issue: Yes ]
- 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. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: Yes ]
- 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. ] [ Designated as safety issue: No ]
Bone marrow transplantation (BMT) patients are immunocompromised to a varying degree depending upon genetic relationship between donor and recipient with compromising therapy required for allogeneic transplants. Responses to influenza vaccine in this population have been poor and yet influenza virus infection can lead to serious disease. There is a need for prophylaxis against influenza in this population. One approach to improving immune responses to influenza vaccines in BMT patients could be to increase dosage and number of doses of vaccine. This approach has increased responses in a variety of populations. Moreover, using purified hemagglutinin (HA) vaccines in the form of rDNA-expressed HA protein in a baculovirus expression system has increased immune responses without an increase in reactogenicity. Researchers hypothesize that an increased dosage and 2 doses of a purified influenza vaccine will increase serum hemagglutination inhibition (HAI) and neutralizing antibody responses significantly over those following 2 doses of conventional vaccine in BMT patients. The primary objective of this study is to determine if 2 doses of a baculovirus-expressed recombinant trivalent influenza vaccine containing less than or equal to 135 mcg per HA results in a significantly higher proportion of subjects achieving a Day 28 and Day 56 post vaccination increase in serum HAI and neutralizing antibody titer than seen after immunization with standard dose licensed trivalent inactivated influenza vaccine in immunosuppressed allogeneic HSCT (Hematopoietic stem cell transplantation) recipients. The secondary objectives include determination of the safety and tolerability of a two-dose regimen of recombinant, baculovirus-expressed HA containing less than or equal to 135 mcg per HA administered by intramuscular injection to patients following allogeneic HSCT, and comparison of the geometric mean titers (GMT) of serum HAI and neutralizing antibody against all 3 virus strains contained in the vaccine. The study will enroll 100 adult (greater than or equal to 18 years of age) allogeneic HSCT recipients between 6 and 12 months following transplantation, with no or stable graft-versus-host disease, who are evaluated at the outpatient BMT clinic at M.D. Anderson Cancer Center. Subjects will be randomized to receive either licensed trivalent inactivated influenza vaccine (TIV) or baculovirus-expressed recombinant trivalent hemagglutinin vaccine (rHA0). All injections will be administered into the deltoid muscle. Subjects will be randomized (50 per group) to receive a vaccination on Day 0 and a second dose 4 weeks later. Subjects will maintain a memory aid to record oral temperature and solicited systemic and local adverse events for 8 days (Day 0 through Day 7) after each immunization. Subjects will return to the clinic on Day 28 for adverse event (AE) and concomitant medication assessment, targeted physical examination if indicated, and a review of the memory aid prior to receiving the second dose of vaccine. Serum for vaccine immunogenicity evaluations will be collected prior to vaccination at Days 0 and 28 and 56 days after the first vaccination. Participants will be involved in study related procedures for 6 months.