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One hundred and twenty-one of 128 enrolled healthy adult subjects were immunized against tick-borne encephalitis (TBE) either by TBE vaccine on days 0 and 28 (61 subjects) or simultaneously by TBE vaccine plus TBE immunoglobulin on day 0 plus TBE vaccine on day 28 (60 subjects). Formation of TBE antibodies were measured in ELISA on days 0, 28 and 56. On day 28 median TBE antibodies were twice as high...
A live-attenuated dengue 2 vaccine (strain 16681 PDK 53) developed at Mahidol University, Thailand was evaluated for safety and immunogenicity by administering 10 4 p.f.u. subcutaneously to ten flavivirus non-immune American volunteers. The vaccine was safe; there were no serious adverse reactions. Eight recipients experienced no or mild side effects. One recipient reported headaches on...
A total of 522 children between 18 months and 14 years and 191 adults between 18 and 60 years were vaccinated with TBE-vaccine according to an abbreviated schedule (0, 7, 21). The aim of the study was to investigate whether reducing the amount of antigen in the vaccination for children would preserve an adequate immune response and decrease the rate of side-effects. Efficacy was determined on the...
Forty-four vaccinees immunized with rabies vaccine and human rabies immunoglobulin according to the abbreviated intramuscular regimen (the 2-1-1 schedule) were followed-up after 1100 days and had their blood samples taken. The persistence of rabies neutralizing antibody was proven in the sera of all vaccinees, 56% of whom demonstrated titres 0.5 IU ml -1 . At the same day the vaccinees...
Vaccine development strategies have often utilized recombinant envelope glycoproteins which usually generate strong humoral immune responses but which do not generate strong cytotoxic T lymphocytes (CTL). A recent novel experimental vaccination approach involves the technology known as nucleic acid immunization in which DNA plasmids expressing a gene of interest is injected intramuscularly in experimental...
A randomized, double-blind trial comparing a diphtheria-tetanus-acellular pertussis vaccine (DTaP) (pertussis toxoid and filamentous hemagglutinin) with a whole-cell vaccine (DTwP) was conducted. A case-contact study was nested in the trial to estimate absolute efficacy. From 1990 through 1994, 4181 children were randomized to receive one of the vaccines at 2, 4, and 6 months. Severe adverse events...
The safety and immunogenicity of REMUNE TM , an HIV-specific immune based therapy for HIV infection, was evaluated in a cohort of 30 HIV infected subjects in Thailand. This therapy utilizes a gp120 depleted inactivated virus (HZ 321 ), which exhibits a high degree of conservation with the core antigens of both type B and E strains of HIV, the predominant Thailand...
In order to evaluate in humans the safety and immunogenicity of a Pseudomonas aeruginosa vaccine composed of outer membrane proteins (OMPs), CFC-101, we carried out a phase I/IIa clinical trial in healthy male volunteers. Groups of six volunteers were immunized either subcutaneously (s.c.) or intramuscularly (i.m.) with three dosages of the vaccine three times at 7-day intervals. The vaccine was well...
Safety and efficacy of killed (autoclaved) L. major promastigotes, ALM, mixed with BCG against zoonotic cutaneous leishmaniasis was tested in healthy volunteers (n=2453) in a randomized double blind trial vs. BCG as control. Side-effects were similar in both groups but tended to be slightly more frequent and prolonged in the ALM+BCG group. Leishmanin skin test conversion (induration ≥5 mm) was significantly...
Calcitriol, also known as 1,25-dihyrody-vitamin D3, is a steroid hormone that has been shown to have effects on cytokine production and lymphocyte proliferation. Coadministration of calcitriol with trivalent influenza vaccine in mice enhanced both mucosal and sytemic antibody responses. We studied the effects of calcitriol coadministered with a commercially available influenza vaccine in 175 human...
PBCC211, an aroA aroD derivative of S. typhi strain CDC10-80, was tested in phase I trials as a single dose typhoid fever vaccine. Three different vaccine preparations, reconstituted lyophilized bacteria, freshly grown bacteria or lyophilized bacteria reconstituted from sachets, were orally administered to a total of 86 adult volunteers. An aroA aroD htrA strain, PBCC222, was also tested in 38 volunteers...
DNA-based vaccines are considered to be potentially revolutionary due to their ease of production, low cost, long shelf life, lack of requirement for a cold chain and ability to induce good T-cell responses. Twenty healthy adult volunteers were enrolled in a Phase I safety and tolerability clinical study of a DNA vaccine encoding a malaria antigen. Volunteers received 3 intramuscular injections of...
A DNA vaccine against the hepatitis B virus (HBV) was evaluated for safety and induction of immune responses in 12 healthy, hepatitis-naı̈ve human volunteers using the needle-free PowderJect™ system to deliver gold particles coated with DNA directly into cells of the skin. Three groups of four volunteers received three administrations of DNA encoding the surface antigen of HBV at one of the three...
The aim of the present study was to compare two immunization schedules for a Pseudomonas aeruginosa outer membrane proteins (OMPs) vaccine in burn patients. In a double-blind, randomized and placebo-controlled clinical trial, 95 adult patients with burn injuries in 10% or greater of total body surface area were randomly allocated to either placebo or immunization groups. Three doses of the vaccine...
A phase I clinical trial was performed to examine the safety and immunogenicity of a multi-epitope polypeptide comprising the central 15 amino acids of the V3 loop from six HIV-1 isolates. This protein called TAB9 was emulsified in Montanide ISA720 (Seppic, Paris) and administered intramuscularly at doses of 0, 0.2 and 1 mg to 24 healthy, HIV-1 seronegative adult males. Three immunisations were given...
Helicobacter pylori urease was expressed in the common live typhoid vaccine Ty21a yielding Ty21a(pDB1). Nine volunteers received Ty21a(pDB1) and three control volunteers received Ty21a. No serious adverse effects were observed in any of the volunteers. Ten out of 12 volunteers developed humoral immune responses to the Salmonella carrier as detected by antigen-specific antibody-secreting cells but...
Objective: To explore whether RSV vaccines are efficacious in preventing respiratory syncytial virus (RSV) lower respiratory infection (LRI). Methods: Randomized clinical trials were sought through Medline using the following search terms: ‘RSV’ or ‘RSV infection’ and ‘viral vaccine’. Randomized controlled trials in adults or children that provided data on clinical outcomes (RSV LRIs, all LRI, all...
Without going into the details of the devastation that human immunodeficiency virus (HIV) infection causes especially in the developing world, the best hope for changing the course of this epidemic is development of a safe, effective, accessible prophylactic HIV vaccine. While the inaccessibility of potentially neutralising epitopes on primary HIV isolates has hampered the development of envelope-based...
SPf66 is a synthetic malaria peptide vaccine, which has been widely tested in combination with aluminium hydroxide (alum) as the adjuvant. Since this formulation is weakly immunogenic, we sought to improve its immunogenicity by using the saponin adjuvant QS-21. SPf66/QS-21 vaccines were evaluated for safety, tolerability and immunogenicity in healthy adults. The vaccines were found to be safe in 87/89...
Attenuated poxviruses have been developed for use as candidate vaccine vectors. ALVAC, a strain of the Avipoxvirus canarypox, has been extensively evaluated as a vector for vaccines against the human immunodeficiency virus type 1 (HIV-1). This report presents the safety and reactogenicity data derived from 11 multicenter, randomized controlled trials of ALVAC-HIV vaccines conducted by the HIV Vaccine...
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