*3.1. Adherence and Tolerability*

54 HIV-1 infected individuals receiving ART participated in the study. All participants were randomized into three equivalent groups: 0.5 mg of vaccine—17 individuals, 0.25 mg—17 individuals, and placebo—20 individuals. Demographic characteristics of trial participants are presented in Table 1.


**Table 1.** Demographic characteristics of trial participants.

Vaccination was fully completed in 53 trial participants. One individual from group vaccinated with 0.25 mg of the vaccine was prematurely withdrawn from the study after first vaccine application due to a cold caused by a respiratory virus. There was no temporal association with vaccine administration, so this AE was determined as unlikely to be associated with the vaccination. However, data on safety and tolerability were analyzed in this participant.

The diagram describing the course of the study is presented at Figure 2.

Adverse events were registered in 17 out of 54 trial participants (31.8%). In the vaccinated groups (0.25 mg and 0.5 mg combined) 35 AE in 12 patients were detected (35.3%), in the placebo group—13 AE in 5 patients (25.0%). In the group receiving 0.25 mg of the vaccine AE were found twice as often as in the group receiving the 0.5 mg dose (47.1% and 23.5% respectively). The total data on the adverse events registered in trial participants are presented in Table 2. Statistically significant differences between the frequencies of adverse events in vaccinated and placebo groups were not found (Fisher's exact test).

Pain in the left arm and hyperemia at the injection site were associated with immunization with the studied candidate vaccine. Fourteen cases of AE were determined to be possibly associated with vaccination including leukopenia, neutropenia, fever, itching at the injection site, hypersecretion from the genital tract, and menstrual disorders.

No deaths were detected. Most adverse events had mild or moderate severity. In the vaccinated groups, 4 cases of 3rd grade AE (3 cases in the 0.25 mg group and 1 case in the 0.5 mg group) and 1 case of 4th grade AE (in the 0.25 mg group) were registered, all of them neutropenias. This did not lead to an interruption of the vaccination. In all cases neutropenias were completely resolved.

*Vaccines* **2019**, *7*, 92

**Figure 2.** Consort diagram of the study.




**Table 2.** *Cont.*

*p* > 0.05.
