A Phase I clinical trial to assess the safety and immunogenicity of HIV DNA-C CN54ENV immunisations administered via the Intramuscular and Intradermal methods with and without electroporation followed by boosting with recombinant HIV CN54gp140 in healthy male and female volunteers.
Assessing the effectiveness of HIV DNA-C CN54ENV immunisations administered by different methods in healthy male and female volunteers.
What was this study about?
There is an urgent need to develop methods to prevent HIV infection, because of the continuing world-wide epidemic; there are an estimated 6850 new infections each day.
To date, several HIV vaccines have been developed, and three have been assessed in a large population at risk of HIV infection. The results of the first two trials were disappointing but the third study showed a small benefit. Although the benefit was too small to lead to a successful vaccine, the positive result has given hope, and led to renewed efforts to strengthen potential HIV vaccines.
CUTHIVAC002 is a randomised trial aimed at exploring the safety and immune responses of two ways of delivering the vaccine The study will look at giving the DNA HIV vaccine to volunteers using two different methods.
Intradermal injection: Injection in the top layer of skin on the upper arm with or without Electroporation (EP)
Intramuscular injection: Into the upper thigh with or without EP
Electroporation is an electrical pulse applied with the vaccine into the upper thigh or arm. The pulse is instant and the whole procedure is completed within a similar time to a normal vaccination.
The vaccine being tested does not contain any active (live) or denatured (killed) whole HIV.
What difference did this study make?
Building on the success of CUTHIVAC-001, this trial assessed administration of DNA using electroporation with the intradermal and intramuscular routes. Electroporation resulted in 100% response in all groups to DNA which is very unusual. Although there was a trend towards higher responses in the group that received electroproation with both routes this was not statistically significant.
Type of study
Who funded the study?
European Commission under the 7th Framework Programme – CUT’HIVAC Grant Agreement.
When did it take place?
2016 to 2017
Where did it take place?
Hammersmith Hospital, London
Who was included?
23 healthy male and female volunteers aged 18 to 50 years old, with a BMI between 18-30, who were at low risk of HIV infection, completed the four vaccines.