HIV-1-Gag Conserved-Element DNA Vaccine (p24CE) as Therapeutic Vaccination in HIV-Infected Persons With Viral Suppression on Antiretroviral Therapy
Phase: PHASE1
Conditions: HIV Infections
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

 
 
 
A5369 Version 1.0, LOA #3 (06/26/20) 
IND Number: 018257 
 
 
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ACTG NETWORK COORDINATING CENTER 
Social & Scientific Systems 
8757 Georgia Avenue, 12th Floor 
Silver Spring, MD  20910-3714 
Phone: (301) 628-3000 
Fax: (301) 628-3302 
 
 
LETTER OF AMENDMENT 
 
DATE:  
June 26, 2020 
 
TO: 
ACTG CTU Principal Investigators, CRS Leaders, and CTU/CRS Coordinators at 
A5369 Protocol-Specific Sites 
 
FROM: 
A5369 Protocol Team  
 
SUBJECT: 
Letter of Amendment #3 for Protocol A5369, Version 1.0, 03/09/18, entitled “HIV-1-
Gag Conserved-Element DNA Vaccine (p24CE) as Therapeutic Vaccination in HIV-
Infected Persons with Viral Suppression on Antiretroviral Therapy” 
 
 
The following information affects the A5369 study and must be forwarded to your 
institutional review board (IRB)/ethics committee (EC) as soon as possible for their 
information and review. This Letter of Amendment (LOA) must be approved by your IRB/EC 
before implementation.  
 
The following information may also affect the Sample Informed Consent. Your IRB/EC is 
responsible for determining the process of informing participants of the contents of this 
LOA. 
 
Upon receiving final IRB/EC and any other applicable regulatory entity approvals for this 
LOA, sites should implement the LOA immediately. Sites are still required to submit an LOA 
registration packet to the Division of AIDS (DAIDS) Protocol Registration Office (PRO) at the 
Regulatory Support Center. Sites will receive a registration notification for the LOA once the 
DAIDS PRO verifies that all required LOA registration documents have been received and 
are complete. An LOA registration notification from the DAIDS PRO is not required prior to 
implementing the LOA. A copy of the LOA registration notification, along with this letter and 
any IRB/EC correspondence, should be retained in the site’s regulatory file. 
 
The main reason for this LOA is to provide guidance for the study visit window in follow-up to the 
COVID-19-related Clarification Memo (CM) #2, dated 04/08/20. The LOA is being implemented to 
further broaden the visit window in light of the feasibility at sites due to COVID-19 situations. 
 
Only new text from this LOA appears in bold. Deletions are shown in strikethrough. 
 
 

 
 
 
A5369 Version 1.0, LOA #3 (06/26/20) 
IND Number: 018257 
 
 
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1. The Title Page has been updated as follows: 
 
DAIDS Clinical Representative: 
Pablo Belaunzaran Zamudio, MD, DTM&H, MSc 
Karin L. Klingman, MD 
 
2. The Protocol Team Roster has been updated as follows: 
 
DAIDS Clinical Representatives  
Karin L. Klingman, MD 
HIV Research Branch 
TRP, DAIDS, NIAID, NIH 
5601 Fishers Lane, Rm 9E40A, MSC 9830  
Rockville, MD 20852 
Phone: 240-627-3067 
E-mail: kklingman@niaid.nih.gov 
 
Pablo Belaunzaran Zamudio, MD, DTM&H, MSc 
HIV Research Branch  
TRP, DAIDS, NIAID, NIH 
5601 Fishers Lane, Rm 9E40B, MSC 9830 
Bethesda, MD 20892 
Phone: 240-627-3067 
E-mail: belaunzaranzapabf@niaid.nih.gov 
 
3. Section 6.2.3, Post-Entry Evaluations, is being updated as shown below. 
 
6.2.3 Post-Entry Evaluations 
 
Post-entry evaluations occur after the study entry visit and vaccination #1 
administration at week 0. Study visits are scheduled as indicated in the SOE. 
 
The visit window for the post-entry evaluations is ±14 days. 
 
Due to the feasibility challenges posed by the COVID-19 situation, starting 03/16/20, 
the visit window is broadened from ±14 days to -14 days to +60 days. The 
broadened visit window is applicable to visits scheduled to occur before 04/30/20. 
This will be reviewed again at a later date to see if the 04/30/20 date should be 
extended (to include visits occurring after 04/30/20), and/or if the visit windows 
themselves need to be extended further. See the update below. 
 
Upon further review, the visit window is broadened from ±14 days to -14 days 
to +180 days for visits that were planned to occur before 07/15/20. While 
+180 days is allowed, sites are encouraged to schedule the applicable visits 
within +90 days. 
 
The week 24 and week 26 visits should remain separate and coordinated to be as 
close to 2 weeks apart as feasible, but can be up to 60 days apart. Thus, if the week 
26 visit has to be delayed, it is better to postpone the week 24 visit until the week 26 
visit can occur 2 weeks later, or as close to that interval as possible. 
 

 
 
 
A5369 Version 1.0, LOA #3 (06/26/20) 
IND Number: 018257 
 
 
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NOTE A: The deferred study vaccinations #2, #3, and #4 should be performed 
within 14 days from the time of the previously scheduled week 4, week 12, and 
week 24 visits, respectively (see section 6.3.10). 
 
NOTE B: After study entry, administration of non-HIV vaccines must occur more 
than 2 weeks prior to the scheduled study vaccination #2 (week 4), #3 (week 12), 
and #4 (week 24) injections. 
 
Study Completion Evaluations  
The week 48 evaluations will be completed as the participant’s final on study visit. 
 
For week 48 visits after 03/16/20, the visit can be a “hybrid” visit, with safety data 
(AEs) and clinical assessment data per section 6.3.4 (Clinical Assessments, 
Concomitant Medications/ARV Medications) collected remotely, and the actual clinic 
visit being dedicated to the lab draw. 
 
4. Protocol Signature Page 
 
Per a regulatory requirement by the DAIDS, a Protocol Signature Page (PSP) is appended for 
submission to the DAIDS Protocol Registration System (DPRS) as part of the LOA registration 
packet. 
 
 

 
 
 
A5369 Version 1.0, LOA #3 (06/26/20) 
IND Number: 018257 
 
 
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HIV-1-Gag Conserved-Element DNA Vaccine (p24CE) as Therapeutic Vaccination in HIV-Infected 
Persons with Viral Suppression on Antiretroviral Therapy 
 
SIGNATURE PAGE 
 
 
I will conduct the study in accordance with the provisions of this protocol and all applicable 
protocol-related documents. I agree to conduct this study in compliance with United States (US) 
Health and Human Service regulations (45 CFR 46); applicable US Food and Drug Administration 
regulations; standards of the International Conference on Harmonization Guideline for Good 
Clinical Practice (E6); Institutional Review Board/Ethics Committee determinations; all applicable 
in-country, state, and local laws and regulations; and other applicable requirements (e.g., US 
National Institutes of Health, Division of AIDS) and institutional policies. 
 
 
 
 
 
Principal Investigator: _____________________________________________________ 
 
Print/Type 
 
 
 
 
 
Signed: _______________________________________________Date: _____________ 
 
Name/Title