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Optimal protection against malaria may require induction of high levels of protective antibody and CD8 + and CD4 + T cell responses. In humans, malaria DNA vaccines elicit CD8 + cytotoxic T cells (CTL) and IFNγ responses as measured by short-term (ex vivo) ELISPOT assays, and recombinant proteins elicit antibodies and excellent T cell responses, but no CD8 + CTL or...
Orally administered recombinant Salmonella vaccines represent an attractive option for mass vaccination programmes against various infectious diseases. Therefore, it is crucial to gather knowledge about the possible impact of preexisiting immunity to carrier antigens on the immunogenicity of recombinant vaccines. Thirteen volunteers were preimmunized with Salmonella typhi Ty21a in order to evaluate...
Hybrid cell vaccines of autologous tumour cells fused with allogenic dendritic cells (DC) combine the tumour's antigenicity with the immune-stimulatory capacity of mature dendritic cells and allogenic MHC class II molecules to activate T cell help and induce tumour-specific cytotoxic T cells. This concept was tested in a clinical trial with melanoma stage III and IV patients. Seventeen patients were...
Plasmodium vivax is responsible for the majority of malaria cases outside of Africa, and results in substantial morbidity. Transmission blocking vaccines are a potentially powerful component of a multi-faceted public health approach to controlling or eliminating malaria. We report the first phase 1 clinical trial of a P. vivax transmission blocking vaccine in humans. The Pvs25H vaccine is a recombinant...
This open single-arm study evaluated whether the administration of an HIV-recombinant canarypox vaccine (vCP1433) in highly active antiretroviral therapy (HAART)-treated patients chronically infected with HIV was safe, immunogenic and associated with prolongation of treatment discontinuation: 48 patients received four monthly vCP1433 injections and stopped HAART. Immunization was safe. HIV-p24-specific...
We conducted a Phase 1b study to evaluate the immunogenicity and safety of two live attenuated tetravalent dengue vaccines in healthy adult volunteers. After one injection, all subjects reported systemic reactions consistent with a mild dengue-like syndrome. Seven volunteers developed dengue 3 viraemia after vaccination. All subjects developed a neutralizing antibody response against serotype 3 with...
Heterologous prime-boost immunisation with RTS,S/AS02A and the poxvirus MVA-CS was evaluated in 18 healthy malaria-naïve subjects in Oxford. Both priming with RTS,S and boosting MVA-CS, and the reverse, were found to be safe and well tolerated. T cell responses as measured by IFN-γ ex vivo ELISPOT were induced, but the responses were low to moderate in both groups, with heterologous boosting yielding...
A phase I clinical trial was conducted to evaluate a monovalent influenza DNA vaccine containing the HA gene from A/Panama/2007/99 delivered by particle-mediated epidermal delivery (PMED). Three groups of 12 healthy adult subjects received a single dose on day 0 of either 1, 2 or 4μg of DNA vaccine, delivered as 1, 2 or 4 PMED administrations. The PMED influenza DNA vaccine elicited serum hemagglutination-inhibition...
VDV3, a clonal derivative of the Mahidol live-attenuated dengue 3 vaccine was prepared in Vero cells. Despite satisfactory preclinical evaluation, VDV3 was reactogenic in humans. We explored whether immunological mechanisms contributed to this outcome by monitoring innate and adaptive cellular immune responses for 28 days after vaccination. While no variations were seen in serum IL12 or TNFα levels,...
A new manufacturing process, known as process upgrade varicella vaccine (PUVV) was developed for a refrigerated formulation of varicella vaccine and for an investigational zoster vaccine. Safety and tolerability of a two-dose regimen of high-titered (∼50,000PFU) PUVV were compared to a lower-titer formulation (∼5400PFU) of VARIVAX™; in 1366 healthy subjects ≥13 years old. Only one vaccine-related...
Use of the recombinant proteins NefTat and gp120 W61D formulated with the AS02A adjuvant system was previously shown to protect against AIDS in a rhesus macaque SHIV animal model system.Eighty-four HIV uninfected human participants were vaccinated intramuscularly at 0, 1, and 3 months and evaluated for safety. Immune responses were analyzed for the presence of vaccine-induced antibody and...
To evaluate immunogenicity and tolerability of a live attenuated zoster vaccine in varicella-zoster virus (VZV) seronegative or low-seropositive adults ≥30 years of age.Double-blind, placebo-controlled, randomized, multicenter study. Subjects were enrolled in two stages by prescreened serostatus. Subjects with a low VZV antibody titer (≤5gpELISA units/mL) were enrolled in Stage 1. Subjects with undetecable...
The glutamate-rich protein (GLURP) of P. falciparum is the target of cytophilic antibodies which are significantly associated with protection against clinical malaria. A phase 1 clinical trial was conducted in healthy adult volunteers with the long synthetic peptide (LSP) GLURP 85–213 combined with either Aluminum Hydroxide (Alum, 18 volunteers) or Montanide ISA 720 (ISA, 18 volunteers) as...
The duration of protection afforded by vaccines represents a critical test of their utility as public health interventions. Some vaccines induce long-term immunity, while others require booster doses. Vaccines that induce long-term protection are usually characterized by the generation of immune memory. Recent trials of a quadrivalent (types 6, 11, 16, 18) human papillomavirus (HPV) vaccine have demonstrated...
Chinese injection drug users (IDUs) may be a proper candidate population for HIV vaccine trials.To evaluate willingness to participate (WTP) in HIV vaccine trials among Chinese IDUs.Questionnaire interviews were completed among 401 IDUs in Urumqi City in northwestern China in 2005.Overall 74.3% of participants said that they would be definitely willing to participate in HIV vaccine trials, 17.7% were...
We report the rationale, design, methods and details of participation of a community-based, double-blind, randomized clinical trial of an HPV 16 and 18 vaccine conducted in two provinces of Costa Rica to investigate the efficacy and population impact of the vaccine in the prevention of cervical cancer precursors. More than 24,000 women between 18 and 25 years of age were invited to participate and...
In a phase III, double blind, randomized, noninferiority, multi-centre clinical trial, 817 infants were included and randomly assigned to vaccination with DTaP-IPV Vero (N=410) or DTaP-IPV Mkc (N=407) vaccines (Statens Serum Institut (SSI), Denmark) in the right thigh. All infants were vaccinated with Act-HIB ® (Sanofi Pasteur, France) in the left thigh at the same time. The...
IAVI-006 was the first large randomised, double-blinded, placebo-controlled Phase I clinical trial to systematically investigate the prime-boost strategy for induction of HIV-1 specific CD8+ cytotoxic T-lymphocytes (CTL) in a factorial trial design using (i) priming with 0.5mg or 2mg of pTHr.HIVA DNA vaccine, followed by (ii) two booster vaccinations with 5×10 7 MVA.HIVA at weeks 8 and 12...
Apical Membrane Antigen 1 (AMA1) and Merozoite Surface Protein 1 (MSP1) were produced as a recombinant fusion protein and formulated with the adjuvant Montanide ISA 720 with the aim of replicating the structure present in the parasite protein. A previous trial with this construct demonstrated the vaccine was safe and immunogenic but was associated with injection site reactogenicity. This Phase 1a...
First generation candidate vaccines against leishmaniasis, prepared using inactivated whole parasites as their main ingredient, were considered as promising because of their relative ease of production and low cost. These vaccines have been the subject of many investigations over several decades and are the only leishmaniasis vaccine candidates which have undergone phase 3 clinical trial evaluation...
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