Human vaccines & immunotherapeutics
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Hum Vaccin Immunother · Sep 2012
Randomized Controlled TrialImmunogenicity and safety of recombinant tetravalent dengue vaccine (CYD-TDV) in individuals aged 2-45 y: Phase II randomized controlled trial in Singapore.
This was a multicenter, blinded, Phase II study (NCT00880893) conducted in Singapore. The primary objectives were to evaluate the safety of a tetravalent dengue vaccine (TDV) comprising four recombinant, live, attenuated viruses (CYD-TDV) and the dengue virus serotype-specific antibody responses before and 28 d after each vaccination. Participants were randomized 3:1 to receive three doses of CYD-TDV or a control vaccine at 0, 6 and 12 mo. ⋯ Post-dose 3, 66.5% of all participants were seropositive to all four serotypes, and 87.2% were seropositive to ≥ 3 serotypes; GMTs for all participants ranged from 43.0 against dengue virus serotype 1 to 100 against dengue virus serotype 4. GMTs were higher in children than in adolescents. These results support the continued development of CYD-TDV for the prevention of dengue disease.
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Hum Vaccin Immunother · Aug 2012
Randomized Controlled Trial Comparative StudyPhase 4 randomized trial of intradermal low-antigen-content inactivated influenza vaccine versus standard-dose intramuscular vaccine in HIV-1-infected adults.
This study evaluated safety, tolerability and immunogenicity of intradermal (ID) trivalent inactivated split influenza vaccine, with a lower antigen content (9 mcg HA per strain) than the conventional intramuscular one (15 mcg), in HIV-1-infected adults younger than 60 years. A total of 54 HIV-1-positive participants were enrolled and randomly assigned to receive a single dose of either ID-administered low-antigen-content split inactivated vaccine or intramuscularly-administered (IM) standard-dose inactivated split vaccine. Subjects were provided with a diary to monitor any local and/or systemic reactions to the vaccine for 7 days following vaccination. ⋯ Both vaccines met mean-fold-increase and seroprotection criteria but failed seroconversion criteria against B virus. No difference in terms of post-vaccination geometric mean titers, mean fold increase, seroprotection and seroconversion rates were found comparing ID and IM vaccines. In conclusion, the recently available low-antigen-content ID vaccine is safe, well-tolerated and as immunogenic as IM standard-dose influenza vaccine.
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Hum Vaccin Immunother · Aug 2012
Randomized Controlled Trial Multicenter StudyLot-to-lot consistency study of the fully liquid pentavalent DTwP-HepB-Hib vaccine Quinvaxem (®) demonstrating clinical equivalence, suitability of the vaccine as a booster and concomitant administration with measles vaccine.
This double-blind, randomized study evaluated the immunogenicity and safety of three production lots of the fully liquid combination DTwP-Hep-Hib vaccine, Quinvaxem (®) (Crucell, The Netherlands) in 360 healthy infants aged 42-64 d old given at 6, 10 and 14 weeks of age (Core Study). The Core Study was followed by an open-label Booster Phase evaluating immunogenicity and safety of a booster dose of Quinvaxem (®) given with either concomitant or deferred measles vaccine in 227 infants who completed the Core Study. One month after the third dose of Quinvaxem (®) immune responses reflecting seroprotection or seroconversion were observed in more than 90% of infants for all three vaccine lots. ⋯ Thus, Quinvaxem (®) was immunogenic and well-tolerated when administered to infants according to a 6-10-14 week vaccination schedule. The three production lots had consistent reactogenicity and immunogenicity profiles. The booster dose of Quinvaxem (®) was also immunogenic and safe, regardless of whether a monovalent measles vaccine was administered concomitantly or one month later.
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Hum Vaccin Immunother · Aug 2012
Clinical TrialEvaluation of immune response following one dose of an AS03A-adjuvanted H1N1 2009 pandemic influenza vaccine in Japanese adults 65 years of age or older.
This study assessed the immunogenicity, long-term persistence of immune response and safety of a single dose of an A/California/07/2009 H1N1 pandemic influenza vaccine adjuvanted with AS03 (α-tocopherol and squalene based oil-in-water emulsion Adjuvant System) in subjects ≥ 65 y of age (NCT01114620). ⋯ A single dose of the 3.75 µg HA AS03-adjuvanted H1N1 2009 pandemic vaccine induced immune responses against the vaccine strain that met the European regulatory guidance criteria at day 21 in the elderly Japanese population; the immune response persisted at lower levels at month 6. No safety concerns were identified. These results suggest that two vaccine doses might be useful for the elderly population to improve antibody induction and persistence.
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Hum Vaccin Immunother · Aug 2012
India is on the way forward to maternal and neonatal tetanus elimination!
Tetanus is an acute, potentially fatal disease, caused by a bacterium, Clostridium tetani. The disease usually occurs in newborns through infection of the unhealed umbilical stump, particularly when the stump is cut with a non-sterile instrument. NT contributes to 5-7% of neonatal mortality worldwide. ⋯ The Government of India (1983) introduced at least two doses of tetanus toxoid vaccine (TT) to all pregnant women during each pregnancy as a part of its nationwide immunization policy. To date, a total of 15 States including union territories of the India have achieved NT elimination. The remaining Indian States need to strengthen TT coverage to save the lives of neonates as well as mothers from tetanus.