Safety profile of candidate HIV vaccines across clinical trial phases: a systematic review of global trajectory
1
Clinical Pharmacy and Pharmacy Management, University of Nigeria, Nsukka, Enugu, Nigeria, Nigeria
2
Babckock University, Ilishan-Remo, Nigeria
3
Nnamdi Azikiwe University, Awka, Nigeria
Popul. Med. 2026;8(Supplement Supplement 1):
ABSTRACT
INTRODUCTION:
The development of vaccines remains a critical tool in the global HIV response. To guide future vaccine development, a thorough assessment of the safety profile of the current vaccine candidates across clinical trial phases is important. This systematic review examines the safety profile of HIV vaccine candidates in various clinical trials to determine their safety profiles.
METHODS:
An extensive literature search was conducted across multiple databases, including Google Scholar, PubMed, Web of Science, and Scopus, using appropriate keywords. The articles were screened for eligibility and only clinical trials involving HIV-negative individuals were included. Quality of studies was assessed using the Newcastle-Ottawa scale, and the results were synthesized narratively.
RESULTS:
Out of the 3,515 studies identified, 113 met the eligibility criteria and were included. The studies were majorly Phase I clinical trials (81 studies out of 113). Across the included studies, the age range of participants varied, but 47 studies involved those within 18-60 years. Notably, 97 studies reported positive immunogenicity outcomes with robust antibody responses. Most studies (109/113) reported mild to moderate adverse effects such as pain, tenderness, and swelling. Minor side effects such as fever, headache, fatigue, and malaise, resolving within hours to a few weeks, were also frequently reported across the trials. Some serious side effects such as atrial fibrillation, epilepsy, and vitiligo, were reported in 20 studies, with some leading to the affected participants’ withdrawal from the study, and even death. However, there is insufficient evidence directly attributing these serious side effects to the vaccine candidates.
CONCLUSIONS:
HIV vaccine candidates have demonstrated a favourable safety profile as adverse events were predominantly mild and moderate. Serious adverse events were rare and without a direct linkage to the vaccine. With the significant immunogenicity demonstrated, the vaccine is a promising tool for revolutionizing HIV prevention and requires further research.
The development of vaccines remains a critical tool in the global HIV response. To guide future vaccine development, a thorough assessment of the safety profile of the current vaccine candidates across clinical trial phases is important. This systematic review examines the safety profile of HIV vaccine candidates in various clinical trials to determine their safety profiles.
METHODS:
An extensive literature search was conducted across multiple databases, including Google Scholar, PubMed, Web of Science, and Scopus, using appropriate keywords. The articles were screened for eligibility and only clinical trials involving HIV-negative individuals were included. Quality of studies was assessed using the Newcastle-Ottawa scale, and the results were synthesized narratively.
RESULTS:
Out of the 3,515 studies identified, 113 met the eligibility criteria and were included. The studies were majorly Phase I clinical trials (81 studies out of 113). Across the included studies, the age range of participants varied, but 47 studies involved those within 18-60 years. Notably, 97 studies reported positive immunogenicity outcomes with robust antibody responses. Most studies (109/113) reported mild to moderate adverse effects such as pain, tenderness, and swelling. Minor side effects such as fever, headache, fatigue, and malaise, resolving within hours to a few weeks, were also frequently reported across the trials. Some serious side effects such as atrial fibrillation, epilepsy, and vitiligo, were reported in 20 studies, with some leading to the affected participants’ withdrawal from the study, and even death. However, there is insufficient evidence directly attributing these serious side effects to the vaccine candidates.
CONCLUSIONS:
HIV vaccine candidates have demonstrated a favourable safety profile as adverse events were predominantly mild and moderate. Serious adverse events were rare and without a direct linkage to the vaccine. With the significant immunogenicity demonstrated, the vaccine is a promising tool for revolutionizing HIV prevention and requires further research.
| eISSN: | 2654-1459 |
We process personal data collected when visiting the website. The function of obtaining information about users and their behavior is carried out by voluntarily entered information in forms and saving cookies in end devices. Data, including cookies, are used to provide services, improve the user experience and to analyze the traffic in accordance with the Privacy policy. Data are also collected and processed by Google Analytics tool (more).
You can change cookies settings in your browser. Restricted use of cookies in the browser configuration may affect some functionalities of the website.
You can change cookies settings in your browser. Restricted use of cookies in the browser configuration may affect some functionalities of the website.
