Randomized, double-blind, placebo-controlled trial to evaluate the safety and immunogenicity of live oral cholera vaccine 638 in Cuban adults.

A randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the safety, reactogenicity and the immunogenicity of a 2 x 10(9)CFU dose of the 638 lyophilized live attenuated cholera vaccine for oral administration, formulated and produced at Finlay Institute, City of Havana, Cuba. Thirty-six healthy female and male adult volunteers from 18 to 40 years old were involved, clinically examined and laboratory tested after the informed consent signature. Adverse events were monitored and seroconversion rates and geometrical mean titer (GMT) of vibriocidal antibodies were tested in volunteer's sera samples. Neither serious adverse events nor other damages to the volunteers due to vaccine or placebo feeding were reported during the clinical follow-up period of this study; none of the adverse events registered within the first 72 h after inoculation were life-threatening for volunteers. Neither severe nor moderate adverse events were reported. Sixty-one percent of subjects showed mild expected adverse events in an interval lower than 24h up to the first 72 h, 75% of these in the vaccinated group and 18% in the placebo group. Fourteen days after inoculation the GMT of vibriocidal antibodies in the vaccine group significantly increased in comparison to the placebo group. All subjects in the vaccine group (24) seroconverted (100%). Results show that this vaccine is safe, well tolerated and immunogenic in healthy female and male volunteers.

The vaccine candidate Vibrio cholerae 638 is protective against cholera in healthy volunteers.

Vibrio cholerae 638 is a living candidate cholera vaccine strain attenuated by deletion of the CTXPhi prophage from C7258 (O1, El Tor Ogawa) and by insertion of the Clostridium thermocellum endoglucanase A gene into the hemagglutinin/protease coding sequence. This vaccine candidate was previously found to be well tolerated and immunogenic in volunteers. This article reports a randomized, double-blind, placebo-controlled trial conducted to test short-term protection conferred by 638 against subsequent V. cholerae infection and disease in volunteers in Cuba. A total of 45 subjects were enrolled and assigned to receive vaccine or placebo. The vaccine contained 10(9) CFU of freshly harvested 638 buffered with 1.3% NaHCO(3), while the placebo was buffer alone. After vaccine but not after placebo intake, 96% of volunteers had at least a fourfold increase in vibriocidal antibody titers, and 50% showed a doubling of at least the lipopolysaccharide-specific immunoglobulin A titers in serum. At 1 month after vaccination, five volunteers from the vaccine group and five from the placebo group underwent an exploratory challenge study with 10(9) CFU of DeltaCTXPhi attenuated mutant strain V. cholerae 81. Only two volunteers from the vaccine group shed strain 81 in their feces, but none of them experienced diarrhea; in the placebo group, all volunteers excreted the challenge strain, and three had reactogenic diarrhea. An additional 12 vaccinees and 9 placebo recipients underwent challenge with 7 x 10(5) CFU of virulent strain V. cholerae 3008 freshly harvested from a brain heart infusion agar plate and buffered with 1.3% NaHCO(3). Three volunteers (25%) from the vaccine group and all from the placebo group shed the challenge agent in their feces. None of the 12 vaccinees but 7 volunteers from the placebo group had diarrhea, and 2 of the latter exhibited severe cholera (>5,000 g of diarrheal stool). These results indicate that at 1 month after ingestion of a single oral dose (10(9) CFU) of strain 638, volunteers remained protected against cholera infection and disease provoked by the wild-type challenge agent V. cholerae 3008. We recommend that additional vaccine lots of 638 be prepared under good manufacturing practices for further evaluation.

[AIDS and hemophilia in pediatrics: report of a case]. / SIDA y hemofilia en pediatría: a propósito de un caso.

It is reported the case of a 12-year-old white school boy with diagnosis of degree III hemophilia A since he was 2 months old that had received innumerable transfusions of cryoprecipitate and several of blood. In 1999, he was diagnosed hepatitis C and, at the end of 2000, HIV infection. There was a high possibility of having acquired them both by the blood and hemoderivative transfusions received. As very low figures of TCD4 lymphocytes (4%) with 54 cells/mm3 were corroborated on conducting immunological studies, it was classified as group B-3 AIDS, according to the classification established by the CDC of Atlanta, in 1994. He was indicated antiretroviral treatment with tritherapy (d4T, 3TC and Nelfinavir). This case was reported to call the attention of doctors at the time of indicating treatment with antivirals or protease-inhibitors to fight AIDS in pediatric cases with diagnosis of hemophilia, since some of them may cause spontaneous bleeding episodes.

La transmisión materno infantil del VIH/SIDA en Cuba / Mother to child transmission of infantile HIV/AIDS in Cuba

The number of children born to HIV/AIDS-seropositive mothers in Cuba is small due to the implementation of the program for the prevention of maternal-infant transmission of HIV/AIDS in Cuba. During the studied period (January 1st, 1985, to December 31st, 1999) 64 children were born, 9 were infected with HIV, 7 of them have developed AIDS (3 have died due to this cause and 4 are under treatment with antiviral agents and proteases inhibitors) and 2 are asymptomatic HIV seropositive. Of the 48 children that concluded the study, 39 (81.25) are sound and 9 (18.75) are HIV/AIDS-seropositive children, which is a low figure of maternal-infant transmission compared with that of the developed countries. Since 1997, when AZT began to be administered to mothers and children, none of the 8 children that finished the study have been infected. Up to now, 10 HIV/AIDS-seropositive children, 9 by perinatal route and 1 by blood transfusion, already dead, have been reported in the country.

Coriorretinitis por toxoplasma en niños / Chorioretinitis caused by toxoplasma in children

In a period of 5 years, 21 children with ocular lesions caused by toxoplasma (chorioretinitis due to toxoplasma) were seen at "Pedro KourÝ" Tropical Medicine Institute. Of the 21 children, 5 (23.8) had lesions in both eyes and 16 (76.1) in one eye (9 in the left eye and 7 in the right one). 9 children (42.8) initially had active lesions that responded satisfactorily to medical treatment whereas 12 (57.1) came to the hospital with healed lesions that did not require any treatment. They were all followed up as outpatients with favorable evolution in all cases.