Efficacy And Safety Of Vaccine Trials Conducted In Africa A Systematic Review And Meta-analysis.

Clinical Trials Project Topics

Get the Complete Project Materials Now! »

Background: vaccine preventable diseases have been of global concern. Vaccines are the bestrnway for prevention. Studies are showing that there is disparity in efficacy of vaccines, inrnindustrialized and in low-middle income countries. Additionally, vaccine related diseases arernsaid to be occurring in recent decades. Africa produces less than one percent of vaccines andrndepends on imports. It is important to check how many of these imported vaccines have beenrnsubjected to clinical trials, to assess efficacy and safety before they are made available to massrnconsumption. This study is aimed to evaluate the vaccine trials conducted up to the end of 2020rnwith no start up period limit to inventory the type of trials undertaken in comparison with thernvaccines that are in routine use in African countries and to assess vaccine effectiveness inrnAfrican settings. rnMethodology: A systematic review and meta-analysis was carried out to assess the vaccine trialsrnconducted in the 54 African countries. Eighteen WHO approved registries, 2 immunizationrnschedule sites and databases were searched. Data were exported to MS excel and RevManrnversion 5.4 for analysis.rnResult: The largest vaccine trial for disease prevention purpose was seen for malaria with 119rn(21.2%) whereas the lowest was for tetanus with 1 (0.2%) trial. Out of these vaccines, BCG andrnOPV are given in all African countries, whereas vaccines for; Hepatitis A Influenza (for bothrnpediatric and adult), MenAC, bOPV, deworming, cholera, DTaP, TdIPV and dtaPHibIP arerngiven only in one country each. From the 26 single disease specific vaccine 17 and from 13rncombination vaccines 4 multi-disease vaccines was found to have gone through clinical trialrnwhich ranges from the lower 1 ( Tetanus) vaccine trial per disease of interest to the highest ofrn119 (Malaria) vaccine trials in the single disease specific trials. BCG and OPV given in allrnAfrican countries (100%) attributed to only 55 (15.5 %) and 2 (0.5%) of the trials, respectively,rnwhereas Malaria vaccine which is given only in 3 (5.5%) of African countries attributed to 119rn(33.6%) of the trials. In the malaria vaccine trial review, highest efficacy [30%, 95% CI (0.59,rn0.84)] was seen against severe malaria in both children and infants. Whereas, the lowest efficacyrn[20%, 95% CI (0.75, 0.86)] was found to be in 1rnstrn episode of malaria in infants. The highestrnefficacy [67%, 95% CI (0.16, 0.66)] was seen in HIV positive adults and the lowest efficacyrn[21%, 95% CI (0.44, 1.42)] was seen in HIV positive infants. The highest efficacy [52%, 95% CI (0.37, 0.61)] of the PCV vaccine was seen against 1rnstrn episode of IPD, and the lowest efficacyrn[13%, 95% CI (0.80, 0.96)] was seen against severe Pneumonia in HIV negative individuals.rnConclusion: The overall efficacy of the three types of vaccines that are included in this reviewrnwas found to be low, and no significant SAEs were found across the vaccines. We found nornvaccines terminated for futility. Safety data of these studies were mainly acquired from phase 3rntrials not phase 4, we couldn’t assess the safety issues identified from outside of a controlledrnenvironment i.e., for a long term effect and the issues seen in general populations.

Get Full Work

Report copyright infringement or plagiarism

Be the First to Share On Social



1GB data
1GB data

RELATED TOPICS

1GB data
1GB data
Efficacy And Safety Of Vaccine Trials Conducted In Africa A Systematic Review And Meta-analysis.

137