A single dose of live-attenuated 638 Vibrio cholerae oral vaccine is safe and immunogenic in adult volunteers in Mozambique
A placebo-controlled randomized, double-blind, clinical trial was carried out to assess the safety, reactogenicity, and immunogenicity of the lyophilized vaccine candidate against cholera derived from the live attenuated 638 Vibrio cholerae O1 El Tor Ogawa strain. One hundred and twenty presumably h...
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| Format: | Article |
| Language: | English |
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Finlay Ediciones
2011-12-01
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| Series: | VacciMonitor |
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| Online Access: | http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S1025-028X2011000300001&lng=es&nrm=iso&tlng=en |
| _version_ | 1818689327188672512 |
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| author | Hilda María García Ricardo Thompson Rodrigo Valera Rafael Fando João Fumane Ilesh Jani Mayelín Mirabal Marlene Isabel Armesto |
| author_facet | Hilda María García Ricardo Thompson Rodrigo Valera Rafael Fando João Fumane Ilesh Jani Mayelín Mirabal Marlene Isabel Armesto |
| author_sort | Hilda María García |
| collection | DOAJ |
| description | A placebo-controlled randomized, double-blind, clinical trial was carried out to assess the safety, reactogenicity, and immunogenicity of the lyophilized vaccine candidate against cholera derived from the live attenuated 638 Vibrio cholerae O1 El Tor Ogawa strain. One hundred and twenty presumably healthy female and male adult volunteers aged between 18 and 50 years were included. They were from Maputo, Mozambique a cholera endemic area, where, in addition, human immunodeficiency virus (HIV) seroprevalence is from 20 to 30%. A dose of 2 x 10 9 colony forming units (CFU) was given to 80 subjects and other 40 received only vaccine lyoprotectors as a placebo control. Out-patient follow-up of adverse events was carried out during the following 30 days after vaccination. The immune response was evaluated by the estimation of seroconversion rate and the geometric mean titer (GMT) of vibriocidal antibodies in the sera from volunteers that was collected previously, and at days 14 and 21 after immunization. No serious adverse events were reported. The adverse events found in the vaccine group were similar to those of the placebo groups. They were independent from the detection of antibodies against HIV-1, HIV-2, hepatitis (H) A; HC and hepatitis B surface antigen. The presence of helminthes did not modify the incidence of adverse events. The 638 vaccine strain was isolated in 37 (46.25%) vaccinated volunteer's feces. The peak of the GMT of vibriocidal antibodies in the vaccine group was 9056 versus 39 in the placebo group at 14 days with a total seroconversion of 97.4% at 21 days. The 638 vaccine candidate is safe and immunogenic in a cholera endemic region. |
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| institution | Directory Open Access Journal |
| issn | 1025-028X 1025-0298 |
| language | English |
| last_indexed | 2024-12-17T12:08:20Z |
| publishDate | 2011-12-01 |
| publisher | Finlay Ediciones |
| record_format | Article |
| series | VacciMonitor |
| spelling | doaj.art-e0a9dcf4edd3439d983d23fc5a213aa02022-12-21T21:49:32ZengFinlay EdicionesVacciMonitor1025-028X1025-02982011-12-0120318A single dose of live-attenuated 638 Vibrio cholerae oral vaccine is safe and immunogenic in adult volunteers in MozambiqueHilda María García0Ricardo Thompson1Rodrigo Valera2Rafael Fando3João Fumane4Ilesh Jani5Mayelín Mirabal6Marlene Isabel Armesto7Instituto Finlay. Centro de Investigación-Desarrollo-Producción de Vacunas. P.O. Box 16017, La Lisa. La Habana, Cuba.Instituto Nacional de Saúde, Instituição de Investigação do Ministério da Saúde, Mozambique.Instituto Finlay. Centro de Investigación-Desarrollo-Producción de Vacunas. P.O. Box 16017, La Lisa. La Habana, Cuba.Centro Nacional de Investigaciones Científicas, P.O. Box 6412, Playa. La Habana, Cuba. Instituto Nacional de Saúde, Instituição de Investigação do Ministério da Saúde, Mozambique. Instituto Nacional de Saúde, Instituição de Investigação do Ministério da Saúde, Mozambique. Instituto Finlay. Centro de Investigación-Desarrollo-Producción de Vacunas. P.O. Box 16017, La Lisa. La Habana, Cuba.Instituto Finlay. Centro de Investigación-Desarrollo-Producción de Vacunas. P.O. Box 16017, La Lisa. La Habana, Cuba.A placebo-controlled randomized, double-blind, clinical trial was carried out to assess the safety, reactogenicity, and immunogenicity of the lyophilized vaccine candidate against cholera derived from the live attenuated 638 Vibrio cholerae O1 El Tor Ogawa strain. One hundred and twenty presumably healthy female and male adult volunteers aged between 18 and 50 years were included. They were from Maputo, Mozambique a cholera endemic area, where, in addition, human immunodeficiency virus (HIV) seroprevalence is from 20 to 30%. A dose of 2 x 10 9 colony forming units (CFU) was given to 80 subjects and other 40 received only vaccine lyoprotectors as a placebo control. Out-patient follow-up of adverse events was carried out during the following 30 days after vaccination. The immune response was evaluated by the estimation of seroconversion rate and the geometric mean titer (GMT) of vibriocidal antibodies in the sera from volunteers that was collected previously, and at days 14 and 21 after immunization. No serious adverse events were reported. The adverse events found in the vaccine group were similar to those of the placebo groups. They were independent from the detection of antibodies against HIV-1, HIV-2, hepatitis (H) A; HC and hepatitis B surface antigen. The presence of helminthes did not modify the incidence of adverse events. The 638 vaccine strain was isolated in 37 (46.25%) vaccinated volunteer's feces. The peak of the GMT of vibriocidal antibodies in the vaccine group was 9056 versus 39 in the placebo group at 14 days with a total seroconversion of 97.4% at 21 days. The 638 vaccine candidate is safe and immunogenic in a cholera endemic region.http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S1025-028X2011000300001&lng=es&nrm=iso&tlng=enLive vaccineattenuated strain 638clinical trialcholera |
| spellingShingle | Hilda María García Ricardo Thompson Rodrigo Valera Rafael Fando João Fumane Ilesh Jani Mayelín Mirabal Marlene Isabel Armesto A single dose of live-attenuated 638 Vibrio cholerae oral vaccine is safe and immunogenic in adult volunteers in Mozambique VacciMonitor Live vaccine attenuated strain 638 clinical trial cholera |
| title | A single dose of live-attenuated 638 Vibrio cholerae oral vaccine is safe and immunogenic in adult volunteers in Mozambique |
| title_full | A single dose of live-attenuated 638 Vibrio cholerae oral vaccine is safe and immunogenic in adult volunteers in Mozambique |
| title_fullStr | A single dose of live-attenuated 638 Vibrio cholerae oral vaccine is safe and immunogenic in adult volunteers in Mozambique |
| title_full_unstemmed | A single dose of live-attenuated 638 Vibrio cholerae oral vaccine is safe and immunogenic in adult volunteers in Mozambique |
| title_short | A single dose of live-attenuated 638 Vibrio cholerae oral vaccine is safe and immunogenic in adult volunteers in Mozambique |
| title_sort | single dose of live attenuated 638 vibrio cholerae oral vaccine is safe and immunogenic in adult volunteers in mozambique |
| topic | Live vaccine attenuated strain 638 clinical trial cholera |
| url | http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S1025-028X2011000300001&lng=es&nrm=iso&tlng=en |
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