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A phase II open and parallel reactogenicity, immunogenicity and safety trivalent meningitis vaccine (Mencevax) trial was conducted on 413 volunteer 2–29-year-old rural residents in Ethiopia in November/December 2005. Adverse events (AE) were monitored at 1h, 1, 2, 3, 7 and 28 days after vaccination. No serious AE occurred except for burn injury (one) and severe malaria (one) after day 28. Irritability...
A toxic N-terminal 180-amino-acid fragment (C180) of pertussis toxin S1 subunit has the most potent ability to induce protective immunity against pertussis toxin (PT) following DNA-based immunization [Kamachi K, Arakawa Y. Infect Immun 2004;72:4293–6]. For the development of a safer pertussis DNA vaccine, three plasmids encoding mutant C180 (C180-R9K, C180-E129G and C180-R9K/E129G) were constructed...
Vietnam currently produces an orally administered, bivalent (O1 and O139) killed whole-cell vaccine and is the only country in the world with endemic cholera to use an oral cholera vaccine in public health practice. In order to allow international use, the vaccine had to be reformulated to meet World Health Organization (WHO) requirements. We performed a randomized, placebo controlled, safety and...
The safety of DTaP–HepB–IPV vaccine coadministered with PCV and Hib was compared with separate administration of DTaP, HepB, IPV, Hib, and PCV at 2, 4, and 6 months of age. Healthy 2-month-old infants (N=1008) were randomized to the two groups. Following dose 1, there was no significant difference between the groups in the incidence of fever >101.3°F. After each dose, the incidence of any fever...
Herpes zoster (HZ) incidence rises with age, especially after 50 years of age, probably due to waning varicella-zoster virus (VZV)-specific immunity. The Shingles Prevention Study [Oxman MN, Levin MJ, Johnson GR, Schmader KE, Straus SE, Gelb LD, et al. A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults, N Engl J Med 2005;352:2271–84], enrolled people ≥60 years of age and...
Two parallel studies evaluated safety and immunogenicity of a prophylactic HIV-1 vaccine in 192 HIV-seronegative, low-risk volunteers. Modified vaccinia virus Ankara (MVA) and plasmid DNA (pTHr) expressed HIV-1 clade A gag p24 and p17 fused to a string of 25 overlapping CD8+ T cell epitopes (HIVA).These studies compared intramuscular, subcutaneous, and intradermal MVA at dosage levels ranging from...
In this paper we present an overview of the literature on efficacy and safety trials of the various pneumococcal conjugate vaccines on the market (PCV7) and in development (PCV9, PCV11 and allegedly PCV10 and PCV13), as well as of observations from post-licensure studies. Seven- (PCV7) and nine-valent PCV (PCV9) are reported to be sufficiently immunogenic after administration of a 3+1 schedule in...
A group of 600 healthy and asymptomatic dogs from Brazilian canine visceral leishmaniasis endemic areas was vaccinated with three sc doses of Leishmune ® which is the industrialized formulation of the FML-saponin, recently licensed for commercialization in Brazil, which previously showed 76–80% vaccine efficacy against canine visceral leishmaniasis. Safety evaluation was performed for 14 days...
The merozoite surface protein-3 long synthetic peptide (MSP3-LSP) comprises the amino acid sequence 186–276 of the Plasmodium falciparum protein MSP3. It is currently in development as an erythrocytic stage (blood stage) malaria vaccine candidate. We report here the first data on the safety, reactogenicity and immunogenicity of three doses of MSP3-LSP, adjuvanted with aluminium hydroxide, in healthy...
In the study reported by Gorse et al. a unique, educational opportunity was lost. The vaccine and biodefense communities almost experienced the rare chance in a Phase I study to scientifically compare head-to-head an early-stage, investigational recombinant anthrax vaccine (rPA102) with the safe, effective and already FDA-licensed anthrax vaccine, AVA (BioThrax ® ). The authors take a stab...
Concerns of immune cross-reactivity, between epitopes of the group A streptococcal (GAS) M-proteins and host proteins have hindered the progress of an effective GAS vaccine. An ideal M-protein based subunit vaccine should not elicit heart tissue cross-reactive antibody responses and should not activate M-protein specific CD4 + T-cells. In the current study we used a bioinformatic and immunoinformatic...
We consider essential, still ignored, basic research aspects of the failed clinical trial (13 March 2006) of a recombinantly expressed humanised superagonist anti-CD28 mAb, TGN14122. Without hindsight, if for approval of the first ever recombinantly expressed anti-CD28 mAb use in humans attention had been paid to the physico-chemical factors and receptor saturation, the possible catastrophe will have...
Epidemic influenza occurs annually throughout the world and is accompanied by excess morbidity and mortality. Increasing the antigen content and topical administration of vaccine are two strategies being explored to improve the immune responses to trivalent inactivated influenza vaccine (TIV). We conducted a randomized, double-blind, placebo-controlled trial to compare the immunogenicity and reactogenicity...
Live vaccines possess the advantage of having access to induce cell-mediated and antibody-mediated immunity; thus in certain cases they are able to prevent infection, and not only disease. Furthermore, live vaccines, particularly bacterial live vaccines, are relatively cheap to produce and easy to apply. Hence they are suitable to immunize large communities or herds. The induction of both cell-mediated...
In a Phase 1 study, 15 healthy subjects were randomized to receive a 13-valent pneumococcal conjugate vaccine (PCV13) and 15 to receive a 23-valent pneumococcal polysaccharide vaccine (23vPS). Antibody responses were measured immediately before and approximately one month after vaccination. Serotype-specific antibodies were measured using an enzyme-linked immunosorbent assay (ELISA) for immunoglobulin...
This short report presents results of an open uncontrolled single centre study which evaluated immunogenicity and safety of a virosome-formulated hepatitis A vaccine (Epaxal ® ) in 14 HIV-positive adult patients and 64 healthy adults receiving a primary immunisation and a booster dose 12 months later. Seroconversion rates (≥20mIU/mL), geometric mean concentration (GMC) of anti-HAV antibodies,...
Early in the development of respiratory syncytial virus (RSV) vaccines severe disease occurred in children after receipt of formalin-inactivated RSV vaccine. Continuing efforts to develop an appropriately attenuated and immunogenic live RSV vaccine have given opportunities to assure that live vaccines are safe through surveillance of children after vaccination. In the present study, the rate of RSV-associated...
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