B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B
Phase: PHASE3
Conditions: HIV Infection, Hepatitis B
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

A5379, Version 3.0 Clarification Memo #1 (31May2023) 
Page 1 of 1 
 
ACTG NETWORK COORDINATING CENTER 
Social & Scientific Systems, Inc., a DLH Holdings Company 
8757 Georgia Avenue, 12th Floor 
Silver Spring, MD  20910-3714 
Phone: 301-628-3000 
 
 
CLARIFICATION MEMO 
 
DATE:  
May 31, 2023 
 
TO: 
 
ACTG CTU Principal Investigators, CRS Leaders, and CTU/CRS Coordinators 
 
FROM: 
A5379 Protocol Team  
 
SUBJECT: 
Clarification Memo #1 for Protocol A5379 Version 3.0 
 
 
This clarification memo (CM) does not result in a change in the protocol informed consent 
document. The Division of AIDS does not require you to forward it to your institutional review 
board (IRB); however, you must follow your IRB’s policies and procedures. If IRB review of 
clarification memos is required at your site, please submit this document for review. 
 
Each site should file a copy of this CM with the protocol for reference. 
 
The protocol clarification contained in this memo should be implemented immediately.  
 
 
The reason for this CM is to clarify that there is no study protocol deviation eCRF and  
to correct a typo. 
 
The following are clarifications (noted in bold or strikethrough) to Protocol A5379, Version 3.0, 
13Dec2022, titled, “B-ENHANCEMENT OF HBV VACCINATION IN PERSONS LIVING WITH HIV 
(BEe-HIVe): Evaluation of HEPLISAV-B.” These clarifications will be included in the next version of 
the A5379 protocol if it is amended at a future date. 
 
1. In section 12.4, the sentence about study protocol deviation eCRF is deleted, as there is no 
study protocol deviation eCRF. 
 
12.4 
Reporting Protocol Deviations 
 
The site principal investigator and staff are responsible for identifying and reporting 
deviations. If protocol deviations are identified, corrective actions are to be developed 
by the site and implemented promptly. Protocol deviations must be reported to the 
IRB/EC per their guidelines. 
 
Refer to the MOPS for the definition of protocol deviation and instructions for completing 
the study protocol deviation eCRF. 
 
2. The date in the header of the protocol Version 3.0 is meant to be 13Dec2022.