Factors associated with reactogenicity to an investigational HIV vaccine regimen in HIV vaccine trials network 702

Rachel Chihana; Jia Jin Kee; Zoe Moodie; Yunda Huang; Holly Janes; Sufia Dadabhai; Alison C. Roxby; Mary Allen; Sheetal Kassim; Vimla Naicker; Craig Innes; Nivashnee Naicker; Thozama Dubula; Nicole Grunenberg; Mookho Malahleha; James G. Kublin; Linda Gail Bekker; Glenda Gray; Johnstone Kumwenda; Fatima Laher

doi:10.1016/j.vaccine.2024.05.039

Factors associated with reactogenicity to an investigational HIV vaccine regimen in HIV vaccine trials network 702

Rachel Chihana, Jia Jin Kee, Zoe Moodie, Yunda Huang, Holly Janes, Sufia Dadabhai, Alison C. Roxby, Mary Allen, Sheetal Kassim, Vimla Naicker, Craig Innes, Nivashnee Naicker, Thozama Dubula, Nicole Grunenberg, Mookho Malahleha, James G. Kublin, Linda Gail Bekker, Glenda Gray, Johnstone Kumwenda, Fatima Laher

Bloomberg School of Public Health

Research output: Contribution to journal › Article › peer-review

Abstract

Background: Reactogenicity informs vaccine safety, and may influence vaccine uptake. We evaluated factors associated with reactogenicity in HVTN 702, a typical HIV vaccine efficacy trial with multiple doses and products. Methods: HVTN 702, a phase 2b/3 double-blind placebo-controlled trial, randomized 5404 African participants aged 18–35 years without HIV to placebo, or ALVAC-HIV (vCP2438) at months 0, 1 and ALVAC-HIV (vCP2438) + Bivalent Subtype C gp120/MF59 at months 3, 6, 12 and 18. Using multivariate logistic regression, we evaluated associations between reactogenicity with clinical, sociodemographic and laboratory variables. Results: More vaccine than placebo-recipients reported local symptoms (all p < 0.001), arthralgia (p = 0.008), chills (p = 0.012) and myalgia (p < 0.001). Reactogenicity was associated with female sex at birth (OR_v = 2.50, OR_p = 1.81, both p < 0.001) and geographic region. Amongst vaccine-recipients, each year of age was associated with 3 % increase in reactogenicity (OR = 1.03, p = 0.002). Conclusion: Vaccine receipt, female sex at birth, older age, and region may affect reactogenicity.

Original language	English (US)
Article number	125991
Journal	Vaccine
Volume	42
Issue number	20
DOIs	https://doi.org/10.1016/j.vaccine.2024.05.039
State	Published - Aug 13 2024

Keywords

Age
Gender
HIV
Reactogenicity
Region
Vaccine

ASJC Scopus subject areas

Molecular Medicine
General Immunology and Microbiology
General Veterinary
Public Health, Environmental and Occupational Health
Infectious Diseases

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10.1016/j.vaccine.2024.05.039

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Chihana, R., Jin Kee, J., Moodie, Z., Huang, Y., Janes, H., Dadabhai, S., Roxby, A. C., Allen, M., Kassim, S., Naicker, V., Innes, C., Naicker, N., Dubula, T., Grunenberg, N., Malahleha, M., Kublin, J. G., Bekker, L. G., Gray, G., Kumwenda, J., & Laher, F. (2024). Factors associated with reactogenicity to an investigational HIV vaccine regimen in HIV vaccine trials network 702. Vaccine, 42(20), Article 125991. https://doi.org/10.1016/j.vaccine.2024.05.039

Chihana, R, Jin Kee, J, Moodie, Z, Huang, Y, Janes, H, Dadabhai, S, Roxby, AC, Allen, M, Kassim, S, Naicker, V, Innes, C, Naicker, N, Dubula, T, Grunenberg, N, Malahleha, M, Kublin, JG, Bekker, LG, Gray, G, Kumwenda, J & Laher, F 2024, 'Factors associated with reactogenicity to an investigational HIV vaccine regimen in HIV vaccine trials network 702', Vaccine, vol. 42, no. 20, 125991. https://doi.org/10.1016/j.vaccine.2024.05.039

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abstract = "Background: Reactogenicity informs vaccine safety, and may influence vaccine uptake. We evaluated factors associated with reactogenicity in HVTN 702, a typical HIV vaccine efficacy trial with multiple doses and products. Methods: HVTN 702, a phase 2b/3 double-blind placebo-controlled trial, randomized 5404 African participants aged 18–35 years without HIV to placebo, or ALVAC-HIV (vCP2438) at months 0, 1 and ALVAC-HIV (vCP2438) + Bivalent Subtype C gp120/MF59 at months 3, 6, 12 and 18. Using multivariate logistic regression, we evaluated associations between reactogenicity with clinical, sociodemographic and laboratory variables. Results: More vaccine than placebo-recipients reported local symptoms (all p < 0.001), arthralgia (p = 0.008), chills (p = 0.012) and myalgia (p < 0.001). Reactogenicity was associated with female sex at birth (ORv = 2.50, ORp = 1.81, both p < 0.001) and geographic region. Amongst vaccine-recipients, each year of age was associated with 3 % increase in reactogenicity (OR = 1.03, p = 0.002). Conclusion: Vaccine receipt, female sex at birth, older age, and region may affect reactogenicity.",

keywords = "Age, Gender, HIV, Reactogenicity, Region, Vaccine",

author = "Rachel Chihana and {Jin Kee}, Jia and Zoe Moodie and Yunda Huang and Holly Janes and Sufia Dadabhai and Roxby, {Alison C.} and Mary Allen and Sheetal Kassim and Vimla Naicker and Craig Innes and Nivashnee Naicker and Thozama Dubula and Nicole Grunenberg and Mookho Malahleha and Kublin, {James G.} and Bekker, {Linda Gail} and Glenda Gray and Johnstone Kumwenda and Fatima Laher",

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year = "2024",

month = aug,

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doi = "10.1016/j.vaccine.2024.05.039",

language = "English (US)",

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AU - Chihana, Rachel

AU - Jin Kee, Jia

AU - Moodie, Zoe

AU - Huang, Yunda

AU - Janes, Holly

AU - Dadabhai, Sufia

AU - Roxby, Alison C.

AU - Allen, Mary

AU - Kassim, Sheetal

AU - Naicker, Vimla

AU - Innes, Craig

AU - Naicker, Nivashnee

AU - Dubula, Thozama

AU - Grunenberg, Nicole

AU - Malahleha, Mookho

AU - Kublin, James G.

AU - Bekker, Linda Gail

AU - Gray, Glenda

AU - Kumwenda, Johnstone

AU - Laher, Fatima

PY - 2024/8/13

Y1 - 2024/8/13

N2 - Background: Reactogenicity informs vaccine safety, and may influence vaccine uptake. We evaluated factors associated with reactogenicity in HVTN 702, a typical HIV vaccine efficacy trial with multiple doses and products. Methods: HVTN 702, a phase 2b/3 double-blind placebo-controlled trial, randomized 5404 African participants aged 18–35 years without HIV to placebo, or ALVAC-HIV (vCP2438) at months 0, 1 and ALVAC-HIV (vCP2438) + Bivalent Subtype C gp120/MF59 at months 3, 6, 12 and 18. Using multivariate logistic regression, we evaluated associations between reactogenicity with clinical, sociodemographic and laboratory variables. Results: More vaccine than placebo-recipients reported local symptoms (all p < 0.001), arthralgia (p = 0.008), chills (p = 0.012) and myalgia (p < 0.001). Reactogenicity was associated with female sex at birth (ORv = 2.50, ORp = 1.81, both p < 0.001) and geographic region. Amongst vaccine-recipients, each year of age was associated with 3 % increase in reactogenicity (OR = 1.03, p = 0.002). Conclusion: Vaccine receipt, female sex at birth, older age, and region may affect reactogenicity.

AB - Background: Reactogenicity informs vaccine safety, and may influence vaccine uptake. We evaluated factors associated with reactogenicity in HVTN 702, a typical HIV vaccine efficacy trial with multiple doses and products. Methods: HVTN 702, a phase 2b/3 double-blind placebo-controlled trial, randomized 5404 African participants aged 18–35 years without HIV to placebo, or ALVAC-HIV (vCP2438) at months 0, 1 and ALVAC-HIV (vCP2438) + Bivalent Subtype C gp120/MF59 at months 3, 6, 12 and 18. Using multivariate logistic regression, we evaluated associations between reactogenicity with clinical, sociodemographic and laboratory variables. Results: More vaccine than placebo-recipients reported local symptoms (all p < 0.001), arthralgia (p = 0.008), chills (p = 0.012) and myalgia (p < 0.001). Reactogenicity was associated with female sex at birth (ORv = 2.50, ORp = 1.81, both p < 0.001) and geographic region. Amongst vaccine-recipients, each year of age was associated with 3 % increase in reactogenicity (OR = 1.03, p = 0.002). Conclusion: Vaccine receipt, female sex at birth, older age, and region may affect reactogenicity.

KW - Age

KW - Gender

KW - HIV

KW - Reactogenicity

KW - Region

KW - Vaccine

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SN - 0264-410X

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JO - Vaccine

JF - Vaccine

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ER -

Factors associated with reactogenicity to an investigational HIV vaccine regimen in HIV vaccine trials network 702

Abstract

Keywords

ASJC Scopus subject areas

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