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Peru-15 (Choleragarde(®)), a live attenuated oral cholera vaccine, is safe and immunogenic in human immunodeficiency virus (HIV)-seropositive adults in Thailand.
Vaccine. 2015 Sep 11; 33(38):4820-6.V

Abstract

BACKGROUND

Many areas with endemic and epidemic cholera report significant levels of HIV transmission. According to the World Health Organization (WHO), over 95% of reported cholera cases occur in Africa, which also accounts for nearly 70% of people living with HIV/AIDS globally. Peru-15, a promising single dose live attenuated oral cholera vaccine (LA-OCV), was previously found to be safe and immunogenic in cholera endemic areas. However, no data on the vaccine's safety among HIV-seropositive adults had been collected.

METHODS

This study was a double-blinded, individually randomized, placebo-controlled trial enrolling HIV-seropositive adults, 18-45 years of age, conducted in Bangkok, Thailand, to assess the safety of Peru-15 in a HIV-seropositive cohort.

RESULTS

32 HIV infected subjects were randomized to receive either a single oral dose of the Peru-15 vaccine with a buffer or a placebo (buffer only). No serious adverse events were reported during the follow-up period in either group. The geometric mean fold (GMF) rise in V. cholerae O1 El Tor specific antibody titers between baseline and 7 days after dosing was 32.0 (p<0.001) in the vaccine group compared to 1.6 (p<0.14) in the placebo group. Among the 16 vaccinees,14 vaccinees (87.5%) had seroconversion compared to 1 of 16 placebo recipients (6.3%). V. cholerae was isolated from the stool of one vaccinee, and found to be genetically identical to the Peru-15 vaccine strain. There were no significant changes in HIV viral load or CD4 T-cell counts between vaccine and placebo groups.

CONCLUSION

Peru-15 was shown to be safe and immunogenic in HIV-seropositive Thai adults.

Authors+Show Affiliations

Siriraj Hospital, Mahidol University, Bangkok, Thailand.International Vaccine Institute, Seoul, Republic of Korea. Electronic address: yhkim@ivi.int.International Vaccine Institute, Seoul, Republic of Korea.Siriraj Hospital, Mahidol University, Bangkok, Thailand.International Vaccine Institute, Seoul, Republic of Korea.Siriraj Hospital, Mahidol University, Bangkok, Thailand.University of the Philippines Manila - National Institutes of Health, Manila, Philippines.Siriraj Hospital, Mahidol University, Bangkok, Thailand.The George Washington University School of Medicine and Health Sciences, Washington, DC, United States; Sabin Vaccine Institute, Washington, DC, United States.International Center for Diarrheal Disease Research, Dhaka, Bangladesh.International Vaccine Institute, Seoul, Republic of Korea.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

26241948

Citation

Ratanasuwan, W, et al. "Peru-15 (Choleragarde(®)), a Live Attenuated Oral Cholera Vaccine, Is Safe and Immunogenic in Human Immunodeficiency Virus (HIV)-seropositive Adults in Thailand." Vaccine, vol. 33, no. 38, 2015, pp. 4820-6.
Ratanasuwan W, Kim YH, Sah BK, et al. Peru-15 (Choleragarde(®)), a live attenuated oral cholera vaccine, is safe and immunogenic in human immunodeficiency virus (HIV)-seropositive adults in Thailand. Vaccine. 2015;33(38):4820-6.
Ratanasuwan, W., Kim, Y. H., Sah, B. K., Suwanagool, S., Kim, D. R., Anekthananon, A., Lopez, A. L., Techasathit, W., Grahek, S. L., Clemens, J. D., & Wierzba, T. F. (2015). Peru-15 (Choleragarde(®)), a live attenuated oral cholera vaccine, is safe and immunogenic in human immunodeficiency virus (HIV)-seropositive adults in Thailand. Vaccine, 33(38), 4820-6. https://doi.org/10.1016/j.vaccine.2015.07.073
Ratanasuwan W, et al. Peru-15 (Choleragarde(®)), a Live Attenuated Oral Cholera Vaccine, Is Safe and Immunogenic in Human Immunodeficiency Virus (HIV)-seropositive Adults in Thailand. Vaccine. 2015 Sep 11;33(38):4820-6. PubMed PMID: 26241948.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Peru-15 (Choleragarde(®)), a live attenuated oral cholera vaccine, is safe and immunogenic in human immunodeficiency virus (HIV)-seropositive adults in Thailand. AU - Ratanasuwan,W, AU - Kim,Y H, AU - Sah,B K, AU - Suwanagool,S, AU - Kim,D R, AU - Anekthananon,A, AU - Lopez,A L, AU - Techasathit,W, AU - Grahek,S L, AU - Clemens,J D, AU - Wierzba,T F, Y1 - 2015/08/01/ PY - 2015/03/27/received PY - 2015/07/21/revised PY - 2015/07/23/accepted PY - 2015/8/5/entrez PY - 2015/8/5/pubmed PY - 2016/6/9/medline KW - HIV-seropositive adult KW - Immunogenicity KW - Live attenuated cholera vaccine KW - Oral cholera vaccine KW - Peru-15 KW - Safety SP - 4820 EP - 6 JF - Vaccine JO - Vaccine VL - 33 IS - 38 N2 - BACKGROUND: Many areas with endemic and epidemic cholera report significant levels of HIV transmission. According to the World Health Organization (WHO), over 95% of reported cholera cases occur in Africa, which also accounts for nearly 70% of people living with HIV/AIDS globally. Peru-15, a promising single dose live attenuated oral cholera vaccine (LA-OCV), was previously found to be safe and immunogenic in cholera endemic areas. However, no data on the vaccine's safety among HIV-seropositive adults had been collected. METHODS: This study was a double-blinded, individually randomized, placebo-controlled trial enrolling HIV-seropositive adults, 18-45 years of age, conducted in Bangkok, Thailand, to assess the safety of Peru-15 in a HIV-seropositive cohort. RESULTS: 32 HIV infected subjects were randomized to receive either a single oral dose of the Peru-15 vaccine with a buffer or a placebo (buffer only). No serious adverse events were reported during the follow-up period in either group. The geometric mean fold (GMF) rise in V. cholerae O1 El Tor specific antibody titers between baseline and 7 days after dosing was 32.0 (p<0.001) in the vaccine group compared to 1.6 (p<0.14) in the placebo group. Among the 16 vaccinees,14 vaccinees (87.5%) had seroconversion compared to 1 of 16 placebo recipients (6.3%). V. cholerae was isolated from the stool of one vaccinee, and found to be genetically identical to the Peru-15 vaccine strain. There were no significant changes in HIV viral load or CD4 T-cell counts between vaccine and placebo groups. CONCLUSION: Peru-15 was shown to be safe and immunogenic in HIV-seropositive Thai adults. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/26241948/Peru_15__Choleragarde_®___a_live_attenuated_oral_cholera_vaccine_is_safe_and_immunogenic_in_human_immunodeficiency_virus__HIV__seropositive_adults_in_Thailand_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(15)01050-6 DB - PRIME DP - Unbound Medicine ER -